Tachifene: detailed information

Package leaflet: Information for the patient

Tachifene 500 mg/150 mg film-coated tablets

Paracetamol/ibuprofen
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you would like more information or advice, ask your pharmacist.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 3 days.

Contents of this leaflet:

What Tachifene is and what it is used for
What you need to know before taking Tachifene
How to take Tachifene
Possible side effects
How to store Tachifene
Contents of the pack and other information

1. What Tachifene is and what it is used for

Tachifene contains paracetamol and ibuprofen.
Paracetamol works by blocking pain signals directed to the brain. It also helps reduce fever.
Ibuprofen belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It relieves pain and reduces inflammation (swelling, redness, or pain).
Tachifene is used for the short-term treatment of pain associated with:

headache
migraine
backache
menstrual pain
toothache
muscle pain
flu and cold symptoms
sore throat
fever.

If you have any questions about this medicine, consult your doctor or pharmacist.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you should know before taking Tachifene

Do not take Tachifene:

if you are allergic to paracetamol or ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
if you have (or have previously had) bleeding from the intestine, black tarry stools, or diarrhoea with blood;
if you have peptic ulcer (e.g. gastric or duodenal ulcer), or have had one recently or in the past;
together with other medicines containing paracetamol or ibuprofene;
if you regularly drink large amounts of alcohol;
if you have severe heart, liver, or kidney failure;
if you have cerebrovascular bleeding or any other active bleeding;
if you have blood disorders;
if you develop asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs;
during the last three months of pregnancy.

Warnings and precautions
What you should know before taking Tachifene
With ibuprofen, signs of an allergic reaction to this medicine have been reported, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain. Stop taking Tachifene immediately and contact your doctor or emergency medical services right away if you notice any of these signs.
Talk to your doctor or pharmacist before taking Tachifene.
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Tachifene if you have:

heart problems, including heart attack, angina (chest pain), history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or TIA, transient ischemic attack);
high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Take special care with Tachifene
Skin reactions
Serious skin reactions have been reported during treatment with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Stop using Tachifene and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Inform your doctor or pharmacist:

if you have liver disease, hepatitis, kidney disease, or difficulty urinating;
if you abuse alcohol or drugs;
if you are allergic to other medicines containing acetylsalicylic acid, other NSAIDs, or any other substance listed at the end of this leaflet;
if you are pregnant or planning to become pregnant;
if you are breastfeeding or plan to breastfeed;
if you are scheduled for surgery;
if you have or have had any other medical conditions, including:
➢ heartburn, indigestion, gastric ulcer, or any other stomach problem;
➢ vomiting blood or intestinal bleeding;
➢ serious skin reactions, such as Stevens-Johnson syndrome;
➢ asthma;
➢ vision problems;
➢ tendency to bleed or other blood disorders;
➢ intestinal disorders, such as ulcerative colitis or Crohn's disease;
➢ swelling of the ankles or feet;
➢ diarrhoea;
➢ genetic or acquired enzyme deficiencies that manifest with neurological complications, skin problems, or occasionally both (e.g. porphyria);
➢ smallpox;
➢ autoimmune diseases, such as systemic lupus erythematosus;
if you have an infection – see section "Infections" below.

Infections
Tachifene may mask symptoms of infection such as fever and pain. Therefore, Tachifene could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the infection symptoms persist or worsen, contact your doctor immediately.
During treatment with Tachifene, inform your doctor immediately if:
If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.
Do not drink alcohol while taking this medicine. The combination of alcohol and Tachifene may cause liver damage.
This product belongs to a class of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine.

Children and adolescents
This product is not recommended for children and adolescents under 18 years of age.

Other medicines and Tachifene
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tachifene may affect or be affected by other medicines. For example:

medicines with anticoagulant effects (i.e. substances that slow blood clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
medicines used to treat epilepsy or seizures;
chloramphenicol, an antibiotic used to treat eye and ear infections;
probenecid, a medicine used to treat gout;
zidovudine, a medicine used to treat HIV (the virus that causes acquired immunodeficiency syndrome);
medicines used to treat tuberculosis, such as isoniazid;
acetylsalicylic acid, salicylates, or other NSAIDs;
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);
diuretics;
lithium, a medicine used to treat certain types of depression;
methotrexate, a medicine used to treat arthritis and some types of cancer;
corticosteroids, such as prednisone, cortisone;
metoclopramide, propantheline;
tacrolimus or ciclosporin, immunosuppressive drugs used after organ transplants;
sulfonylureas, medicines used to treat diabetes;
certain antibiotics (such as quinolones);
flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

These medicines may be affected by Tachifene or may affect its proper action. It may be necessary to adjust the dosage of these medicines or replace them with others.
Other medicines may also affect or be affected by treatment with Tachifene.
Therefore, always consult your doctor or pharmacist before using Tachifene with other medicines.
Your doctor or pharmacist can provide you with further information about these and other medicines that require caution or should be avoided while taking this medicine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during the last three months of pregnancy.
This may cause kidney or heart problems in the unborn baby. It may affect your or your baby's tendency to bleed and may cause delayed or prolonged labour.
During the first six months of pregnancy, this product should not be used unless strictly necessary and under medical advice.
If treatment is needed during this period or while trying to conceive, the lowest effective dose should be used for the shortest possible time. If taken for more than a few days from the 20th week of pregnancy onwards, this product may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring. This product may impair female fertility and is not recommended for women trying to conceive.

Driving and using machines
Be cautious when driving or using machines until you know how Tachifene affects you.

Tachifene contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to take Tachifene

Take this medicine exactly as directed by your doctor or pharmacist. These instructions may differ from those contained in this leaflet. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is:
Adults: The recommended dose is 1 or 2 tablets to be taken every 6 hours, as needed, up to a maximum of 6 tablets in 24 hours.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Consult your doctor if symptoms persist or worsen after 3 days of treatment.
Do not take more than 6 tablets in 24 hours.
If your doctor prescribes a different dose, follow your doctor's instructions.
Take Tachifene tablets with food or immediately after meals with a glass of water.
The break line is intended to facilitate tablet swallowing if you have difficulty ingesting it whole, and not for dividing the tablet into equal doses.

Use in children and adolescents under 18 years of age
Tachifene is not recommended for children and adolescents under 18 years of age.

If you take more Tachifene than you should
If you think that you or someone else has taken an excessive amount of Tachifene, contact your doctor immediately or go to the nearest hospital emergency department. Do this even if no symptoms or signs of poisoning are present.
If you have taken more Tachifene than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and guidance on actions to take.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and uncontrolled eye movements. In addition, agitation, drowsiness, disorientation, or coma may occur. Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may be reported.
Furthermore, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. Asthma may worsen in patients with asthma. In addition, low blood pressure and reduced respiratory function may occur.
Urgent medical attention may be required.

If you forget to take Tachifene
If the time for your next dose is approaching, do not take the missed dose and take the next dose at the scheduled time.
Otherwise, take it as soon as you remember, and then continue taking the tablets as usual.
Do not take a double dose to make up for the forgotten dose.
If you are unsure whether to skip the dose, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to your doctor or pharmacist if you experience any side effects.
If you experience any of the following serious side effects, stop taking Tachifene and
contact your doctor immediately or go to the nearest hospital emergency department:

vomiting blood or material resembling coffee grounds;
rectal bleeding, black and tarry stools, or diarrhoea with blood;
swelling of the face, lips, or tongue which may cause difficulty swallowing or breathing;
asthma, wheezing, shortness of breath;
very rare cases of serious skin reactions have been reported, including sudden or severe itching, rash, hives;
fever, general feeling of illness, nausea, stomach ache, headache, and neck stiffness;
flat, reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome);
widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized pustular eruption).

Other side effects:
Common (may affect up to 1 in 10 people)

fluid retention, swelling;
ringing in the ears (tinnitus);
abdominal pain;
nausea, vomiting, diarrhoea;
discomfort, heartburn or pain in the upper stomach;
skin rashes (including maculopapular type), itching;
headache;
dizziness;
nervousness;
changes in liver or kidney function (determined by blood tests).

Uncommon (may affect up to 1 in 100 people)

reduced number of red blood cells, reduced haemoglobin, bleeding episodes such as epistaxis (nosebleeds), abnormal or prolonged menstrual bleeding, increased platelet count;
changes in certain blood tests (increased aspartate aminotransferase, alkaline phosphatase, and creatine phosphokinase);
eye problems such as blurred or reduced vision, dark spots in the visual field (scotoma), colour vision disturbances, double vision;
flatulence and constipation;
gastric ulcer, intestinal perforation or bleeding with blood in stools (melena) and/or in vomit (haematemesis);
mouth ulcers (ulcerative stomatitis);
worsening of inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
inflammation of the stomach (gastritis) and pancreas (pancreatitis);
increased sensitivity to allergic reactions, angioedema (symptoms may include itching, red and irritated eyes, swelling of face, lips or tongue with possible difficulty in swallowing or breathing), serum sickness (an allergy-like reaction);
lupus erythematosus (a chronic autoimmune disease);
Henoch-Schönlein purpura (inflammation of small blood vessels);
breast enlargement (in men);
abnormally low blood sugar levels (hypoglycaemia);
mood changes, such as depression, confusion, excessive emotional instability;
sleep disturbances (drowsiness or insomnia);
inflammation of the meninges (aseptic meningitis) with fever and coma;
difficulty in urinating;
thick respiratory secretions (mucus).

Rare (may affect up to 1 in 1,000 people)

hallucinations and increased frequency of nightmares;
numbness or abnormal skin sensation (e.g., burning, tingling, or pricking).

Very rare (may affect up to 1 in 10,000 people)

blood disorders: signs of frequent or serious infections such as fever, severe chills, sore throat, or mouth ulcers; increased bleeding or bruising, reddish or purplish spots under the skin; signs of anaemia such as fatigue, headache, shortness of breath, and pallor;
impaired liver function, hepatitis, and yellowing of the skin and/or eyes, also known as jaundice;
dizziness;
low potassium levels in the blood;
blood changes due to increased levels of acidic substances (metabolic acidosis);
abnormal reactivity, optic nerve inflammation (optic neuritis), psychomotor disturbances;
involuntary muscle movements/spasms, tremors and seizures, slowed physical and emotional reactions;
sunburn-like symptoms (such as redness, itching, swelling, blistering) which may occur more rapidly than usual;
fast or irregular heartbeat, known as tachycardia or palpitations, arrhythmia, and other heart rhythm disturbances;
hypertension and heart failure;
increased sweating;
skin reactions with peeling and blister formation (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis);
fatigue and malaise;
hypersensitivity reactions including skin rashes;
acute and chronic kidney damage, including renal failure;
acute kidney injury associated with liver damage;
hyperreactivity of the respiratory system which may present as asthma, worsening of asthma, bronchospasm (narrowing of the airways), and difficulty breathing.

Not known (frequency cannot be estimated from the available data)

a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cells);
a widespread, red, scaly rash with pustules under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Tachifene and contact your doctor immediately if you develop these symptoms. See also section 2.
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
a serious condition that may make the blood more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

The list above includes serious side effects requiring medical attention. Serious side effects are rare at low doses of this medicine and when taken for a short period of time.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tachifene

Keep this medicine out of the sight and reach of children.
Store below 30°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after “EXP”.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the packaging is torn or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tachifene contains
The active substances are paracetamol and ibuprofen.
The other components are: maize starch, pregelatinized maize starch, microcrystalline cellulose,
sodium croscarmellose, magnesium stearate, talc and white Opadry (containing HMPC -
hydroxypropylmethylcellulose/ipromellose (E464), monohydrate lactose, titanium dioxide (E171), macrogol/PEG
4000 and sodium citrate dihydrate (E331)).
Description of the appearance of Tachifene and package contents
Tachifene film-coated tablets are white, capsule-shaped tablets, 19 mm long, with a score line on one side and smooth on the other side. The score line is intended to facilitate breaking the tablet if you have difficulty swallowing it whole, and is not intended for dividing the tablet into equal doses.
Each blister contains 8, 10 or 16 film-coated tablets. Not all pack sizes may be marketed.
Each blister contains 20, 24, 30 or 32 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A
Viale Amelia 70
00181 Rome, Italy.
Manufacturer
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona – Italy.
This medicinal product is authorized in the European Economic Area countries under the following
names:
Italy: Tachifene 500 mg/150 mg film-coated tablets.

Patient Information Leaflet

Tachifene 500 mg/150 mg powder for oral solution in sachet

Paracetamol/ibuprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need further information or advice, consult your pharmacist.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

What Tachifene is and what it is used for
What you need to know before taking Tachifene
How to take Tachifene
Possible side effects
How to store Tachifene
Contents of the pack and other information

2. What Tachifene is and what it is used for

Tachifene contains paracetamol and ibuprofen.
Paracetamol works by blocking the transmission of pain signals to the brain. It also helps reduce fever.
Ibuprofen belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It relieves pain and reduces inflammation (swelling, redness, or pain).
Tachifene is used for the short-term treatment of pain associated with:

headache
migraine
backache
menstrual pain
toothache
muscle pain
symptoms of flu and common cold
sore throat
fever.

If you have any questions about this medicine, consult your doctor or pharmacist.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

4. What you should know before taking Tachifene

Do not take Tachifene:

if you are allergic to paracetamol or ibuprofen, or to any of the other ingredients of this medicine (listed in section 6);
if you have (or have previously had) intestinal bleeding, tarry black stools, or diarrhoea with blood;
if you suffer from peptic ulcer (e.g. gastric or duodenal ulcer), or have had one recently or in the past;
together with other medicines containing paracetamol or ibuprofen;
if you regularly drink large amounts of alcohol;
if you have severe heart, liver, or kidney failure;
if you have cerebrovascular bleeding or any other active bleeding;
if you suffer from blood disorders;
if you develop asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs;
during the last three months of pregnancy.

Warnings and precautions
What you should know before taking Tachifene
Allergic reactions to this medicine, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop taking Tachifene immediately and contact your doctor or emergency medical services right away if you notice any of these symptoms.
Talk to your doctor or pharmacist before taking Tachifene.
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Tachifene if you have:

heart problems, including heart attack, angina (chest pain), history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or TIA, transient ischemic attack);
high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Take special care with Tachifene
Skin reactions
Serious skin reactions have been reported with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Stop using Tachifene and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Inform your doctor or pharmacist:

if you have liver disease, hepatitis, kidney disease, or difficulty urinating;
if you abuse alcohol or drugs;
if you are allergic to other medicines containing acetylsalicylic acid, other NSAIDs, or any other substance listed at the end of this leaflet;
if you are pregnant or planning to become pregnant;
if you are breastfeeding or plan to breastfeed;
if you have an ongoing infection;
if you are scheduled for surgery;
if you have or have had other medical conditions, including:
➢ heartburn, indigestion, gastric ulcer, or any other stomach problem;
➢ vomiting blood or intestinal bleeding;
➢ serious skin reactions, such as Stevens-Johnson syndrome;
➢ asthma;
➢ vision problems;
➢ tendency to bleed or other blood disorders;
➢ intestinal disorders, such as ulcerative colitis or Crohn's disease;
➢ swelling of ankles or feet;
➢ diarrhoea;
➢ genetic or acquired enzyme deficiencies that manifest with neurological complications, skin problems, or occasionally both (e.g. porphyria);
➢ smallpox;
➢ autoimmune diseases, such as systemic lupus erythematosus.
➢ if you have an infection – see section "Infections" below.

Infections
Tachifene may mask symptoms of infections such as fever and pain. Therefore, [medicinal product name] could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
During treatment with Tachifene, inform your doctor immediately if:
You suffer from serious conditions, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.
Do not drink alcohol while taking this medicine. The combination of alcohol and Tachifene may cause liver damage.
This product belongs to a class of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine.

Children and adolescents
This product is not recommended for children and adolescents under 18 years of age.

Other medicines and Tachifene
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tachifene may affect or be affected by other medicines. For example:

medicines with anticoagulant effects (i.e. substances that slow blood clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
medicines used to treat epilepsy or seizures;
chloramphenicol, an antibiotic used to treat eye and ear infections;
probenecid, a medicine used to treat gout;
zidovudine, a medicine used to treat HIV (the virus that causes acquired immunodeficiency syndrome);
medicines used to treat tuberculosis, such as isoniazid;
acetylsalicylic acid, salicylates, or other NSAIDs;
medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);
diuretics;
lithium, a medicine used to treat certain types of depression;
methotrexate, a medicine used to treat arthritis and certain types of cancer;
corticosteroids, such as prednisone, cortisone;
metoclopramide, propantheline;
tacrolimus or ciclosporin, immunosuppressant drugs used after organ transplants;
sulphonamides, medicines used to treat diabetes;
certain antibiotics (such as quinolones);
flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

These medicines may be affected by Tachifene or may affect its proper action. It may be necessary to adjust the doses of these medicines or replace them with others.
Other medicines may also influence or be influenced by treatment with Tachifene.
Therefore, always consult your doctor or pharmacist before using Tachifene with other medicines.
Your doctor or pharmacist can provide further information about these and other medicines to be cautious with or avoid while taking this medicine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during the last three months of pregnancy.
This may cause kidney or heart problems in the unborn child. It may affect your or your baby's tendency to bleed and may cause delayed or prolonged labour.
During the first six months of pregnancy, this product should not be used unless strictly necessary and under medical advice.
If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, this product may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
This product may impair female fertility and is not recommended for women wishing to conceive.

Driving and using machines
Be careful when driving or operating machinery until you know how Tachifene affects you.

Tachifene oral solution powder contains 62.5 mg of aspartame per dose, equivalent to 0.0625 g/2.5 g per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly eliminate it.

Tachifene oral solution powder contains sucrose:
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially "sodium-free".

5. How to take Tachifene

Always take this medicine exactly as your doctor or pharmacist has told you. These instructions may differ from those contained in this leaflet. If you are unsure, consult your doctor or pharmacist.

Recommended dose:
Adults: The recommended dose is 1 or 2 sachets every 6 hours, as needed, up to a maximum of 6 sachets in 24 hours.
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms. If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Consult your doctor if symptoms persist or worsen after 3 days of treatment.
Do not take more than 6 sachets in 24 hours.
If your doctor has prescribed a different dose, follow your doctor's instructions.

To take the oral solution, dissolve the contents of the sachet in a glass of warm (not boiling) water or cold water. Take the medicine immediately after dissolving in water.

Use in children and adolescents under 18 years of age
Tachifene is not recommended for children and adolescents under 18 years of age.

If you take more Tachifene than you should
If you think that you or someone else has taken too much Tachifene, contact your doctor immediately or go to the nearest hospital emergency department. Do this even if no symptoms or signs of poisoning are present.
If you have taken more Tachifene than recommended, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and what actions to take.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and uncontrolled eye movements. In addition, agitation, drowsiness, disorientation, or coma may occur. Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported.
Furthermore, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute kidney failure and liver damage may also occur. Asthma may be exacerbated in patients with asthma. In addition, low blood pressure and reduced respiratory capacity may occur.
Urgent medical attention may be required.

If you forget to take Tachifene
If the time for your next dose is approaching, do not take the missed dose and take the next dose at the scheduled time. Otherwise, take it as soon as you remember, and then continue taking the medicine as usual.
Do not take a double dose to make up for a forgotten dose.
If you are unsure whether you should skip the dose, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or pharmacist if you experience any side effects.
If you experience any of the following serious side effects, stop taking Tachifene and
contact your doctor immediately or go to the nearest hospital emergency department:

vomiting blood or material resembling ground coffee;
rectal bleeding, black and tarry stools, or diarrhoea with blood;
swelling of the face, lips, or tongue that may cause difficulty swallowing or breathing;
asthma, wheezing, shortness of breath;
very rare cases of serious skin reactions have been reported, including sudden or severe itching, rash, hives;
fever, general feeling of illness, nausea, stomach pain, headache, and neck stiffness;
flat, reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption).

Other side effects:
Common (may affect up to 1 in 10 people)

fluid retention, swelling
ringing in the ears (tinnitus)
abdominal pain
nausea, vomiting, diarrhoea
discomfort, heartburn, or pain in the upper stomach
skin rashes (including maculopapular type), itching
headache
dizziness
nervousness
changes in liver or kidney function (as determined by blood tests).

Uncommon (may affect up to 1 in 100 people)

reduced number of red blood cells, reduced haemoglobin, bleeding episodes such as nosebleeds (epistaxis), abnormal or prolonged menstrual bleeding, increased platelet count
changes in certain blood tests (increased aspartate aminotransferase, alkaline phosphatase, and creatine phosphokinase)
eye problems such as blurred or reduced vision, dark spots in the visual field (scotoma), colour vision disturbances, double vision
flatulence and constipation
gastric ulcer, intestinal perforation or bleeding with blood in stools (melena) and/or in vomit (haematemesis)
mouth ulcers (ulcerative stomatitis)
worsening of inflammatory bowel diseases (ulcerative colitis and Crohn's disease)
inflammation of the stomach (gastritis) and pancreas (pancreatitis)
increased sensitivity to allergic reactions, angioedema (symptoms may include itching, red and irritated eyes, swelling of the face, lips, or tongue with possible difficulty swallowing or breathing), serum sickness (an allergy-like reaction)
lupus erythematosus (a chronic autoimmune disease)
Henoch-Schönlein purpura (an inflammation of small blood vessels)
breast enlargement (in men)
abnormally low blood sugar levels (hypoglycaemia)
mood changes, such as depression, confusion, excessive emotional instability
sleep disturbances (drowsiness or insomnia)
inflammation of the meninges (aseptic meningitis) with fever and coma
difficulty urinating
thick respiratory secretions (mucus).

Rare (may affect up to 1 in 1,000 people)

hallucinations and increased frequency of nightmares
numbness or abnormal skin sensation (e.g., burning, tingling, or pricking).

Very rare (may affect up to 1 in 10,000 people)

blood disorders: signs of frequent or severe infections such as fever, severe chills, sore throat, or mouth ulcers; increased bleeding or bruising, red or purple spots under the skin; signs of anaemia such as fatigue, headache, shortness of breath, and pallor
impaired liver function, hepatitis, and yellowing of the skin and/or eyes, also known as jaundice
dizziness
low potassium levels in the blood
blood changes due to increased levels of acidic substances (metabolic acidosis)
abnormal reactivity, optic nerve inflammation (optic neuritis), psychomotor disturbances
involuntary muscle movements/spasms, tremors, and seizures, slowed physical and emotional reactions
sunburn-like symptoms (such as redness, itching, swelling, blistering) that may occur more rapidly than usual
fast or irregular heartbeat, known as tachycardia or palpitations, arrhythmia, and other heart rhythm disturbances
hypertension and heart failure
increased sweating
skin reactions with peeling and blistering (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis)
fatigue and malaise
hypersensitivity reactions including skin rashes
acute and chronic kidney damage, including renal failure
acute kidney injury associated with liver damage
hyperreactivity of the respiratory system, which may present as asthma, worsening of asthma, bronchospasm (narrowing of the airways), and difficulty breathing.

Not known (frequency cannot be estimated from the available data)

a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell)
a widespread, red, scaly rash with pustules under the skin and blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Tachifene if you develop these symptoms and contact your doctor immediately. See also section 2.
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
Severe condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness using paracetamol (see section 2).

The list above includes serious side effects requiring medical attention. Serious side effects are rare at low doses of this medicine and when taken for a short period of time.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tachifene

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. Store in the original packaging to protect
the medicine from light.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the packaging is torn or shows any signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tachifene oral solution powder contains:
The active substances are paracetamol and ibuprofen.
The other components are: aspartame (E951), turmeric extract 95% (E100), lemon flavour, sodium citrate
dihydrate (E331), sucrose.
Description of the appearance of Tachifene and the contents of the pack
Tachifene oral solution powder is presented in sachets made of 3-layer laminate (paper/Alu/PE),
in packs of 8, 10 and 16 sachets. Not all pack sizes may be marketed.
Tachifene oral solution powder is presented in sachets made of 3-layer laminate (paper/Alu/PE),
in packs of 20 and 32 sachets. Not all pack sizes may be marketed.
Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A
Viale Amelia 70
00181 Rome, Italy.
Manufacturer
E-Pharma Trento S.p.A. - Via Provina, 2, 38123 Trento (TN) - Italy

Patient Information Leaflet

Tachifene 1000 mg/300 mg powder for oral solution in sachet

Paracetamol/ibuprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tachifene is and what it is used for
What you need to know before taking Tachifene
How to take Tachifene
Possible side effects
How to store Tachifene
Package contents and other information

1. What Tachifene is and what it is used for

Tachifene contains paracetamol and ibuprofen.
Paracetamol works by blocking pain signals from reaching the brain. It also helps reduce fever.
Ibuprofen belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It relieves pain and reduces inflammation (swelling, redness, or pain).
Tachifene is used for the short-term treatment of pain associated with:

headache
migraine
back pain
menstrual pain
toothache
muscle pain
flu and cold symptoms
sore throat
fever.

If you have any questions about this medicine, consult your doctor or pharmacist.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you should know before taking Tachifene

Do not take Tachifene:

if you are allergic to paracetamol or ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
if you have experienced (or have previously experienced) intestinal bleeding, black tarry stools, or diarrhoea with blood;
if you suffer from peptic ulcer (e.g. gastric or duodenal ulcer), or have suffered from it recently or in the past;
together with other medicines containing paracetamol or ibuprofen;
if you regularly drink large amounts of alcohol;
if you have severe heart, liver, or kidney failure;
if you have cerebrovascular bleeding or any other active bleeding;
if you have blood disorders;
if you develop asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs;
during the last three months of pregnancy.

Warnings and precautions
What you should know before taking Tachifene
Allergic reactions to this medicine, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop taking Tachifene immediately and contact your doctor or emergency medical services if you notice any of these signs.
Consult your doctor or pharmacist before taking Tachifene.
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking Tachifene if you have:

heart problems, including heart attack, angina (chest pain), history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or TIA, transient ischemic attack);
high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Use particular caution with Tachifene
Skin reactions
Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Stop using Tachifene and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Inform your doctor or pharmacist:

if you have liver disease, hepatitis, kidney disease, or difficulty urinating;
if you abuse alcohol or drugs;
if you are allergic to other medicines containing acetylsalicylic acid, other NSAIDs, or any other substance listed at the end of this leaflet;
if you are pregnant or planning to become pregnant;
if you are breastfeeding or plan to breastfeed;
if you have an ongoing infection;
if you are scheduled for surgery;
if you have or have had other medical conditions, including:
➢ heartburn, indigestion, gastric ulcer, or any other stomach problem;
➢ vomiting blood or intestinal bleeding;
➢ serious skin reactions, such as Stevens-Johnson syndrome;
➢ asthma;
➢ vision problems;
➢ tendency to bleed or other blood disorders;
➢ intestinal disorders, such as ulcerative colitis or Crohn's disease;
➢ swelling of ankles or feet;
➢ diarrhoea;
➢ genetic or acquired deficiencies of certain enzymes that manifest with neurological complications, skin problems, or occasionally both (e.g. porphyria);
➢ smallpox;
➢ autoimmune diseases, such as systemic lupus erythematosus.
➢ if you have an infection – see section "Infections" below.

Infections
Tachifene may mask symptoms of infection such as fever and pain. Therefore, [name of medicine] could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
During treatment with Tachifene, inform your doctor immediately if:
If you suffer from severe conditions, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties with deep rapid breathing, drowsiness, nausea, and vomiting.
Do not drink alcohol while taking this medicine. The combination of alcohol and Tachifene may cause liver damage.
This product belongs to a class of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine.

Children and adolescents
This product is not recommended for children and adolescents under 18 years of age.

medicines with anticoagulant effects (i.e. substances that slow blood clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
medicines used to treat epilepsy or seizures;
chloramphenicol, an antibiotic used to treat eye and ear infections;
probenecid, a medicine used to treat gout;
zidovudine, a medicine used to treat HIV (the virus causing acquired immunodeficiency syndrome);
medicines used to treat tuberculosis, such as isoniazid;
acetylsalicylic acid, salicylates, or other NSAIDs;
medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);
diuretics;
lithium, a medicine used to treat certain types of depression;
methotrexate, a medicine used to treat arthritis and some types of cancer;
corticosteroids, such as prednisone, cortisone;
metoclopramide, propanteline;
tacrolimus or ciclosporin, immunosuppressant drugs used after organ transplants;
sulphonamides, medicines used to treat diabetes;
certain antibiotics (such as quinolones);
flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

These medicines may be affected by Tachifene or may affect its proper action. It may be necessary to adjust the dosage of these medicines or replace them with others.
Other medicines may also influence or be influenced by treatment with Tachifene.
Therefore, always consult your doctor or pharmacist before using Tachifene with other medicines.
Your doctor or pharmacist will provide further information about these and other medicines to pay attention to or avoid while taking this medicine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during the last three months of pregnancy.
This may cause kidney or heart problems in the unborn baby. It may affect your or your baby's tendency to bleed and may cause delayed or prolonged labour.
During the first six months of pregnancy, this product should not be administered unless strictly necessary and under medical advice.
If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, this product may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.
This product may impair female fertility and is not recommended for women wishing to conceive.

Driving and using machines
Be cautious when driving or operating machinery until you know how Tachifene affects you.

Tachifene contains 125 mg of aspartame per dose, equivalent to 0.125 g/5 g per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

Tachifene contains sucrose:
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to take Tachifene

Take this medicine exactly as directed by your doctor or pharmacist. These instructions may differ from those contained in this leaflet. If you have any doubts, consult your doctor or pharmacist.

Recommended dose:
Adults:
The recommended dose is 1 sachet every 6 hours, as needed, up to a maximum of 3 sachets in 24 hours.
Dissolve the contents of the sachet in a glass of warm (not boiling) or cold water. Take the medicine immediately after dissolving in water.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. Consult your doctor if symptoms persist or worsen after 3 days of treatment.
Do not take more than 3 sachets in 24 hours.
If your doctor has prescribed a different dose, follow your doctor's instructions.

Use in children and adolescents under 18 years of age
Tachifene is not recommended for children and adolescents under 18 years of age.

If you take more Tachifene than you should
If you think that you or someone else has taken an excessive amount of Tachifene, contact your doctor immediately or go to the nearest hospital emergency department. Do this even if no symptoms or signs of poisoning are present.
If you have taken more Tachifene than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and guidance on necessary actions.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and uncontrolled eye movements. In addition, agitation, drowsiness, disorientation, or coma may occur. Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing problems may be reported.
Furthermore, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute kidney failure and liver damage may also occur. Asthma may worsen in patients with asthma. In addition, low blood pressure and reduced respiratory function may occur.
Urgent medical assistance may be required.

If you forget to take Tachifene
If it is almost time for the next dose, do not take the missed dose. Take the next dose at the scheduled time.
Otherwise, take the missed dose as soon as you remember, and then continue taking the sachets as usual.
Do not take a double dose to make up for a forgotten dose.
If you are unsure whether to skip the dose, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Talk to your doctor or pharmacist if you experience any side effects.
If you experience any of the following serious side effects, stop taking Tachifene and contact your doctor immediately or go to the nearest hospital emergency department:

vomiting blood or material that looks like coffee grounds;
rectal bleeding, black and tarry stools, or diarrhoea with blood;
swelling of the face, lips, or tongue, which may cause difficulty swallowing or breathing;
asthma, wheezing, shortness of breath;
very rare cases of serious skin reactions have been reported, including sudden or severe itching, rash, hives;
extensive blistering and bleeding of the lips, eyes, mouth, nose, and genitals (Stevens-Johnson syndrome);
fever, general feeling of illness, nausea, stomach pain, headache, and neck stiffness;
flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome);
widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear early in treatment (generalized pustular eruption).

Other side effects:
Common (may affect up to 1 in 10 people)

fluid retention, swelling
ringing in the ears (tinnitus)
abdominal pain
nausea, vomiting, diarrhoea
discomfort, heartburn, or pain in the upper stomach
skin rashes (including maculopapular rash), itching
headache
dizziness
nervousness
changes in liver or kidney function (detected by blood tests).

Uncommon (may affect up to 1 in 100 people)

reduced number of red blood cells, reduced haemoglobin, bleeding episodes such as nosebleeds (epistaxis), abnormal or prolonged menstrual bleeding, increased platelet count
changes in certain blood tests (increased aspartate aminotransferase, alkaline phosphatase, and creatine phosphokinase)
eye problems such as blurred or reduced vision, dark spots in the visual field (scotoma), colour vision disturbances, double vision
flatulence and constipation
gastric ulcer, intestinal perforation, or intestinal bleeding with blood in stools (melena) and/or in vomit (haematemesis)
mouth ulcers (ulcerative stomatitis)
worsening of inflammatory bowel diseases (ulcerative colitis and Crohn's disease)
inflammation of the stomach (gastritis) and pancreas (pancreatitis)
increased sensitivity to allergic reactions, angioedema (symptoms may include itching, red and irritated eyes, swelling of face, lips, or tongue with possible difficulty swallowing or breathing), serum sickness (an allergy-like reaction)
erythematous lupus (a chronic autoimmune disease)
Henoch-Schönlein purpura (inflammation of small blood vessels)
breast enlargement in men (gynaecomastia)
abnormally low blood sugar levels (hypoglycaemia)
mood changes, such as depression, confusion, excessive emotional instability
sleep disturbances (drowsiness or insomnia)
inflammation of the meninges (aseptic meningitis) with fever and coma
difficulty urinating
thick respiratory secretions (mucus).

Rare (may affect up to 1 in 1,000 people)

hallucinations and increased frequency of nightmares
numbness or abnormal skin sensations (e.g., burning, tingling, or prickling).

Very rare (may affect up to 1 in 10,000 people)

blood disorders: signs of frequent or severe infections, such as fever, severe chills, sore throat, or mouth ulcers; increased bleeding or bruising, red or purple spots under the skin; signs of anaemia, such as fatigue, headache, shortness of breath, and pallor
impaired liver function, hepatitis, and yellowing of the skin and/or eyes (jaundice)
dizziness
low potassium levels in the blood
blood changes due to increased levels of acidic substances (metabolic acidosis)
abnormal reactivity, optic nerve inflammation (optic neuritis), psychomotor disturbances
involuntary muscle movements/spasms, tremors, and seizures, slowed physical and emotional reactions
sunburn-like symptoms (such as redness, itching, swelling, blistering) that may occur more rapidly than usual
fast or irregular heartbeat, known as tachycardia or palpitations, arrhythmia, and other heart rhythm disorders
hypertension and heart failure
increased sweating
skin reactions with peeling and blistering (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis)
fatigue and malaise
hypersensitivity reactions including skin rashes
acute and chronic kidney damage, including renal failure
acute kidney injury associated with liver damage
increased reactivity of the respiratory system, which may present as asthma, worsening of asthma, bronchospasm (narrowing of the airways), and breathing difficulties.

Not known (frequency cannot be estimated from available data)

a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell)
a widespread, red, scaly rash with pustules under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Tachifene and contact your doctor immediately if you develop these symptoms. See also section 2.
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
a serious condition that may make the blood more acidic (called metabolic acidosis), in patients with a severe illness taking paracetamol (see section 2).

The list above includes serious side effects requiring medical attention. Serious side effects are rare at low doses of this medicine and when taken for a short period of time.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tachifene

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton and blister after “EXP”.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the packaging is torn or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

Description of the appearance of Tachifene and contents of the pack
Tachifene oral solution powder is presented in sachets made of a 3-layer laminate (paper/Alu/PE),
available in packs of 8, 10, 16, 20 and 32 sachets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A
Viale Amelia 70
00181 Rome, Italy.

Manufacturer
E-Pharma Trento S.p.A. - Via Provina, 2 38123 Trento (TN) - Italy