Diclofenac Almus

Package leaflet: Information for the user

DICLOFENAC ALMUS 75 mg/3 ml solution for injection

Generic medicine
Please read all of this leaflet carefully before you use 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 reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DICLOFENAC ALMUS is and what it is used for
2. What you need to know before using DICLOFENAC ALMUS
3. How to use DICLOFENAC ALMUS
4. Possible side effects
5. How to store DICLOFENAC ALMUS
6. Contents of the pack and other information

1. What DICLOFENAC ALMUS is and what it is used for

DICLOFENAC ALMUS contains the active substance diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that work by reducing inflammation and pain.
This medicine is indicated for the treatment of:

• severe pain caused by inflammation of muscles and joints;
• severe abdominal pain caused by spasms of the smooth muscle of internal organs (for example, the intestine).

2. What you need to know before using DICLOFENAC ALMUS

Do not use DICLOFENAC ALMUS

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from gastrointestinal lesions (ulcers), bleeding or perforation in the stomach or intestine;
• if you have previously experienced bleeding or perforation in the stomach or intestine due to treatment with NSAIDs, or if you have had recurrent bleeding/peptic ulcer (two or more distinct episodes of proven ulceration or bleeding);
• if you are in the last trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if you have severe liver, kidney or heart disease;
• if you suffer from heart problems or impaired blood circulation to the brain (established cardiopathy and/or cerebrovascular disease), for example if you have had a heart attack, stroke, mini-stroke (TIA), or obstruction of blood vessels supplying the heart or brain, or undergone surgery to remove or prevent such obstructions;
• if you suffer or have suffered from circulatory problems (peripheral arterial disease);
• if you previously experienced an allergic reaction such as asthma, nasal inflammation or skin irritation after taking anti-inflammatory medicines containing acetylsalicylic acid or other pain or anti-inflammatory medicines belonging to the NSAID group;
• if the patient is a child or adolescent;
• if you are a woman of childbearing potential and are not using an effective contraceptive method to prevent pregnancy (see section “Pregnancy” for further information).

Warnings and precautions
Talk to your doctor or pharmacist before using DICLOFENAC ALMUS:

• if you are pregnant or planning to become pregnant (see section “Pregnancy”). Treatment with Diclofenac Almus must be stopped immediately due to the risk to the fetus.
• if you are a woman of childbearing potential (also see section on “Pregnancy”). It is important to use effective contraceptive measures during treatment with this medicine.
• if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before using DICLOFENAC ALMUS, as DICLOFENAC ALMUS may sometimes impair wound healing in the intestine following surgery;
• if you think you may be allergic to sodium diclofenac, aspirin, ibuprofen or other NSAIDs, or to any of the excipients in DICLOFENAC ALMUS (listed at the end of this leaflet). Signs of hypersensitivity reactions include swelling of the face and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash or any other allergic-type reaction.

Inform your doctor and use this medicine with caution in the following cases:

• if you are elderly or debilitated; in this case, the lowest effective dose is recommended to avoid an increased frequency of adverse effects, especially stomach bleeding and perforation, which can be fatal;
• if you have any stomach or intestinal problems such as lesions (ulcers), ulcerative colitis or Crohn’s disease; in these cases, accurate diagnosis and close medical supervision during treatment are required;
• if you have liver problems or a liver disease called hepatic porphyria; in these cases, accurate diagnosis and close medical supervision during treatment are required;
• if you have kidney problems, as the medicine may cause fluid retention and swelling due to fluid accumulation (edema);
• if you have heart problems (high blood pressure, uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease) and/or cerebrovascular circulation problems (cerebrovascular disease); in these cases, use of this medicine is recommended only after careful medical evaluation. Furthermore, if you are at high risk of developing such conditions (elevated blood lipid levels (hyperlipidemia), diabetes, smoking), it is recommended to use the lowest effective dose for the shortest possible duration;
• if you have blood disorders; in this case, platelet aggregation should be closely monitored, as there may be coagulation problems, especially with prolonged treatment;
• if you suffer from asthma, seasonal allergic rhinitis, nasal mucosa swelling (nasal polyps), obstructive lung diseases, chronic respiratory tract infections, or other allergic reactions such as skin reactions, pruritus or urticaria. In these cases, breathing difficulties (bronchospasm) or even severe allergic reactions such as anaphylactic shock may occur. Inform your doctor if you experience any of the following symptoms during treatment:
• gastrointestinal bleeding or ulceration. In this case, stop treatment. Caution is advised in patients taking other medicines that may increase the risk of ulceration or bleeding, such as acetylsalicylic acid, systemic corticosteroids, anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors (see section “Other medicines and DICLOFENAC ALMUS”). In such cases, concomitant use of a gastroprotective agent (proton pump inhibitors or misoprostol) may be beneficial;
• if you develop severe skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis). These reactions typically occur within the first month of treatment. Discontinue treatment at the first sign of skin rash, mucosal lesions, or any other reaction.

Before taking diclofenac, ensure your doctor is aware:

• if you have heart problems, a history of stroke, or think you may be at risk for these conditions;
• if you smoke;
• if you have diabetes;
• if you suffer from chest pain due to heart problems (angina), blood clots, high blood pressure, high cholesterol or triglyceride levels.

This medicine may increase the risk of cardiovascular problems, especially when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment.
Adverse effects can be minimized by using the lowest effective dose for the shortest necessary duration.
This medicine should not be considered a simple painkiller and must be used under strict medical supervision. Use of vials for treatment beyond 2 days is permitted only in hospitals or healthcare facilities; otherwise, oral therapy should be substituted.

Children and adolescents
DICLOFENAC ALMUS is contraindicated in children and adolescents due to lack of safety and efficacy data for this medicine.

Other medicines and DICLOFENAC ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diclofenac may interact with or be affected by other medicines containing the following active substances:

• lithium, a medicine used for psychiatric disorders;
• digoxin, a medicine used in the treatment of heart conditions;
• medicines used to lower blood pressure such as diuretics (including potassium-sparing diuretics), beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin II antagonists;
• other anti-inflammatory medicines (both NSAIDs and corticosteroids);
• anticoagulant and antiplatelet medicines used to improve blood circulation such as warfarin;
• medicines used for depression such as selective serotonin reuptake inhibitors (SSRIs);
• medicines used for diabetes;
• methotrexate, a medicine used for psoriasis, rheumatism, and certain cancers;
• cyclosporine, a medicine used after organ transplants;
• quinolone antibiotics, used to treat infections;
• phenytoin, a medicine used for epilepsy;
• colestipol and cholestyramine, medicines used to reduce intestinal fat absorption;
• sulfinpyrazone, voriconazole, or other medicines that inhibit diclofenac metabolism, which may lead to increased effects of the medicine.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, do not take Diclofenac Almus.
Inform your doctor if you are planning a pregnancy.
Due to the potential risk of harm to the fetus, you must ensure you are not pregnant before starting treatment. Women of childbearing potential must use reliable contraceptive methods during treatment with this medicine.
Your doctor will inform you of the risks if you become pregnant while taking Diclofenac Almus, as it may cause miscarriage, premature birth, or fetal malformations (congenital defects). You must NEVER take this medicine if you are pregnant, as it may have serious consequences for the baby, particularly affecting the heart, lungs and/or kidneys, including death. If you have received treatment with this medicine during pregnancy, consult your doctor. If you decide to continue the pregnancy, careful ultrasound monitoring of the pregnancy is required, with particular attention to limbs and head.
Do not take Diclofenac Almus during the last three months of pregnancy, as it may harm the fetus or cause delivery complications. It may cause kidney and heart problems in the fetus. It could affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take Diclofenac Almus during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used.
From week 20 of pregnancy onwards, Diclofenac Almus may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause 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.

Breastfeeding
If you are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not use Diclofenac Almus during breastfeeding.

Driving and using machines
This medicine may cause visual disturbances, dizziness, vertigo, drowsiness, or other central nervous system disorders. Avoid driving vehicles or operating machinery if you experience these symptoms.

DICLOFENAC ALMUS contains sodium metabisulfite, benzyl alcohol, propylene glycol and sodium

• This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.
• This medicine contains 120 mg of benzyl alcohol in each 3 ml vial. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
• This medicine contains 600 mg of propylene glycol in each 3 ml vial. If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
• This medicine contains less than 1 mmol of sodium (23 mg) per vial, thus essentially 'sodium-free'.

3. How to use DICLOFENAC ALMUS

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The recommended dose is 1 vial per day, administered by deep intramuscular injection into the upper outer quadrant of the buttock.
In more severe cases, 2 vials per day may be given (one in each buttock), spaced several hours apart; alternatively, one vial of injectable diclofenac may be combined with other pharmaceutical forms (tablets, suppositories) up to a maximum daily dosage of 150 mg of diclofenac.
This medicine must not be administered for more than two consecutive days; if further treatment is needed, it may be continued with diclofenac tablets or suppositories.

Use in children
Intramuscular and intravenous injection of diclofenac is contraindicated in the treatment of children and adolescents.

Use in the elderly
In elderly patients, the doctor will adjust the dosage according to the patient's condition.

If you use more DICLOFENAC ALMUS than you should
Overdose may cause symptoms such as vomiting, gastrointestinal bleeding, diarrhoea, dizziness, ringing in the ears (tinnitus), or seizures. In more severe cases, serious kidney problems (acute renal failure) and liver damage may occur.
If you accidentally take an excessive dose of DICLOFENAC ALMUS, contact your doctor immediately or go to the nearest hospital.

If you forget to use DICLOFENAC ALMUS
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects may be serious.
Stop taking Diclofenac Almus and inform your doctor immediately if you notice:

• Reactions at the injection site, including pain, redness, swelling, hard nodule, ulcers, and bruising. These reactions may worsen with darkening and death of the skin and underlying tissues surrounding the injection site, which then heal with scarring; this condition is known as Nicolau syndrome.
• Mild abdominal cramps and tenderness occurring shortly after starting treatment with Diclofenac Almus, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data);
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

This medicine, especially when used at high doses and for long periods, may increase the risk of heart and brain problems (arterial thrombotic events, such as heart attack or stroke).
The following side effects may occur:
Common (may affect up to 1 in 10 people)

• headache and dizziness;
• vertigo;
• nausea, vomiting, diarrhoea, digestive disturbances (dyspepsia), abdominal pain, flatulence, decreased appetite (anorexia);
• liver function abnormalities (increased transaminases);
• skin rash;
• reaction at the injection site, pain and hardening at the injection site;
• swelling due to fluid retention (oedema);
• fetal malformation;

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

• allergic reactions, even severe ones such as anaphylactic and anaphylactoid reactions (including hypotension and shock);
• drowsiness;
• asthma and breathing difficulties (dyspnoea);
• stomach disorders such as gastritis, bleeding in the stomach and intestines, blood in vomit (haematemesis), blood in stools (haemorrhagic diarrhoea, melena), gastrointestinal ulcer (with or without bleeding or perforation, sometimes fatal, particularly in elderly patients);
• liver problems such as hepatitis and yellowing of the skin and whites of the eyes (jaundice);
• skin irritation (urticaria);

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

• decrease in blood platelets (thrombocytopenia);
• decrease in white blood cells (leucopenia, agranulocytosis);
• decrease in red blood cells in the blood (anaemia, including haemolytic and aplastic anaemia);
• swelling of the skin and mucous membranes, particularly affecting the face (angioneurotic oedema);
• disorientation, depression, insomnia, nightmares, irritability, psychotic reactions;
• altered sensation in limbs (paraesthesia), tremors;
• memory impairment, seizures, anxiety, inflammation of the brain (aseptic meningitis), taste disturbances, cerebrovascular events;
• vision disorders, blurred vision, double vision (diplopia);
• perception of ringing in the ear (tinnitus), worsening of hearing;
• increased awareness of heartbeats (palpitations);
• chest pain, heart failure, myocardial infarction;
• increased blood pressure (hypertension);
• inflammation of blood vessels (vasculitis);
• lung inflammation (pneumonitis);
• intestinal inflammation (colitis), including haemorrhagic colitis and worsening of ulcerative colitis or Crohn's disease;
• constipation, intestinal blockage (diaphragm-like intestinal stenosis);
• inflammation of the mouth (stomatitis, including ulcerative stomatitis), tongue (glossitis), oesophagus, or pancreas (pancreatitis);
• severe liver problems (fulminant hepatitis, hepatic necrosis, liver failure);
• inflammation of the skin and mucous membranes such as blistering rashes, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis;
• hair loss;
• sensitivity to light (photosensitivity);
• skin redness with bleeding (purpura, allergic purpura);
• itching;
• kidney problems such as acute renal failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis;
• presence of blood or protein in urine (haematuria, proteinuria);
• inflammation at the injection site with pus formation (abscess).

Frequency not known (frequency cannot be estimated from available data)

• asthenia;
• tissue damage at the injection site;
• cutaneous drug embolism (Nicolau syndrome).

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 DICLOFENAC ALMUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Store below 25 °C. Keep in the original packaging to protect the medicine from light.
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

What DICLOFENAC ALMUS contains

• The active substance is sodium diclofenac. Each vial contains 75 mg of sodium diclofenac.
• The other components are: mannitol (E 421), sodium metabisulfite (E 223), benzyl alcohol, propylene glycol (E 1520), sodium hydroxide, water for injections.

Description of the appearance of DICLOFENAC ALMUS and package contents
Injectable solution in a pack containing 5 vials of 75 mg/3 ml.
Marketing Authorization Holder
Almus S.r.l. – Via Cesarea, 11/10 – 16121 – Genoa - Italy
Manufacturer
Esseti Farmaceutici S.r.l. - Via Campobello 15 - 00071 Pomezia (Rome) - Italy.