Totalip

Package leaflet: Information for the user

TOTALIP 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Atorvastatin
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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What TOTALIP is and what it is used for

TOTALIP belongs to a class of medicines called statins, which regulate lipid (fat) levels.
TOTALIP is used to reduce lipid levels in the blood, known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes have not been successful.
If you are at high risk of cardiovascular disease, TOTALIP may also be used to reduce this risk, even if cholesterol levels are normal. During treatment, you must continue a standard cholesterol-lowering diet.

2. What you need to know before taking TOTALIP

Do not take TOTALIP

• if you are allergic to atorvastatin or to any of the other ingredients of this medicine (listed in section 6)
• if you have or have had liver disease
• if liver function tests have shown unexplained abnormal results
• if you are a woman of childbearing age and are not using a reliable method of contraception
• if you are pregnant or planning to become pregnant
• if you are breastfeeding
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking TOTALIP:

• if you suffer from severe respiratory failure
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and TOTALIP can cause serious muscle problems (rhabdomyolysis)
• if you have previously had a stroke with cerebral haemorrhage or if you have low fluid reserves in the brain due to previous strokes
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have previously experienced repeated or unexplained muscle pain, or have a personal or family history of muscle disorders
• if you have previously had muscle problems during treatment with other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class)
• if you regularly consume large amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years old
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen myasthenia or cause its onset (see section 4).

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with TOTALIP to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken concomitantly (see section 2 “Other medicines and TOTALIP”).
Furthermore, inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medicines may be needed to diagnose and treat this condition.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in the blood, if you are overweight, and if you have high blood pressure.

Other medicines and TOTALIP
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may alter the effect of TOTALIP or the effect of these medicines may be altered by TOTALIP. Such interactions may reduce the effect of one or both medicines. Alternatively, they may increase the risk or severity of adverse effects, including a condition of muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to modify the way the immune system works, e.g. cyclosporine
• Certain antibiotics or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid
• Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
• Certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus
• Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Other medicines known to interact with TOTALIP include ezetimibe (which lowers cholesterol), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomachache and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium and magnesium)
• Over-the-counter medicines: St. John’s wort
• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart TOTALIP. Taking TOTALIP with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

TOTALIP with food and drink
See section 3 for instructions on how to take TOTALIP. Please note the following:
Grapefruit juice
Do not drink more than one or two small glasses per day of grapefruit juice, as large quantities of grapefruit juice may alter the effects of TOTALIP.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, consult section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Do not take TOTALIP if you are pregnant or planning to become pregnant.
Do not take TOTALIP if you are of childbearing age unless you are using an effective method of contraception.
Do not take TOTALIP if you are breastfeeding.
The safety of TOTALIP during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine usually does not affect the ability to drive or use machines. However, do not drive if this medicine impairs your ability to drive. Do not use tools or machines if your ability to use them is impaired by this medicine.

TOTALIP contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

TOTALIP contains benzoic acid
10 mg film-coated tablet
This medicine contains 0.0004 mg of benzoic acid per tablet
20 mg film-coated tablet
This medicine contains 0.0008 mg of benzoic acid per tablet
40 mg film-coated tablet
This medicine contains 0.0016 mg of benzoic acid per tablet
80 mg film-coated tablet
This medicine contains 0.0032 mg of benzoic acid per tablet

TOTALIP contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take TOTALIP

Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must follow both before and during therapy with TOTALIP.
The usual starting dose of TOTALIP is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose gradually until the required dose is reached. Your doctor will adjust the dosage at intervals of 4 weeks or more. The maximum dose of TOTALIP is 80 mg once daily.
TOTALIP tablets should be swallowed whole with water and may be taken at any time of day, with or without food. However, try to take the tablets at the same time each day.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The duration of treatment with TOTALIP is determined by your doctor.
If you feel that the effect of TOTALIP is too strong or too weak, consult your doctor.
If you take more TOTALIP than you should
If you accidentally take too many TOTALIP tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take TOTALIP
If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose to make up for the missed tablet.
If you stop treatment with TOTALIP
If you have any doubts about using this medicine or wish to discontinue treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects or symptoms, stop taking your tablets immediately and contact your doctor or go to the nearest hospital emergency department.
Rare (may affect up to 1 in 1,000 people):

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to significant breathing difficulties.
• A serious condition associated with severe peeling and swelling of the skin, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with reddish spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters.
• If you experience weakness, discomfort, muscle pain or tearing, or changes in urine colour (turning red-brown), especially if you also feel unwell and have a high fever, this may be due to abnormal breakdown of muscles (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin; it can be life-threatening and may lead to kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may indicate a liver disorder. You should contact your doctor as soon as possible.
• Lupus-like illness (including skin rash, joint problems, and effects on blood cells).

Other side effects that may occur with TOTALIP
Common (may affect up to 1 in 10 people):

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels closely), increased creatine kinase in the blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Changes in liver function laboratory tests

Uncommon (may affect up to 1 in 100 people):

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels closely)
• Nightmares, insomnia
• Dizziness, reduced sensitivity or tingling in the fingers and toes, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain)
• Hepatitis (inflammation of the liver)
• Skin rash, skin eruption and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (oedema), increased body temperature
• Positive urine test for white blood cells

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

• Vision disorders
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon damage

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

• Allergic reaction – symptoms may include sudden wheezing and chest pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse

• Hearing loss

• Gynaecomastia (enlargement of the breasts in men)
  Not known (frequency cannot be estimated from the available data):

• Persistent muscle weakness

• Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing)

• Ocular myasthenia (a disease causing weakness of the eye muscles)
  If you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath, consult your doctor immediately.

Possible side effects reported with some statins (medicines of the same type):

• Sexual difficulties
• Depression
• Breathing difficulties including persistent cough and/or shortness of breath or fever
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, if you are overweight, and if you have high blood pressure. Your doctor will monitor you during treatment with this medicine.
  Reporting of side effects
  If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 TOTALIP

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the label or the carton after
 Exp.  . The expiry date refers to the last day of that month.
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 TOTALIP Contains
The active substance in TOTALIP is atorvastatin.
Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components are:
calcium carbonate (E170), microcrystalline cellulose (E460), lactose monohydrate, sodium croscarmellose,
polysorbate 80 (E433), hypromellose (E463), and magnesium stearate (E572).

The coating of TOTALIP tablets contains hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc (E553b), simethicone, emulsifying stearates, thickening agents (methylcellulose, xanthan gum), benzoic acid, and sorbic acid.

Description of the Appearance of TOTALIP and Contents of the Package
The 10 mg film-coated tablets of TOTALIP are white and round. They are marked with “10” on one side and “ATV” on the other.
The 20 mg film-coated tablets of TOTALIP are white and round. They are marked with “20” on one side and “ATV” on the other.
The 40 mg film-coated tablets of TOTALIP are white and round. They are marked with “40” on one side and “ATV” on the other.
The 80 mg film-coated tablets of TOTALIP are white and round. They are marked with “80” on one side and “ATV” on the other.

Blister packs consist of a sheet made of polyamide/aluminum and polyvinyl chloride, and a sealing foil made of aluminum with a vinyl thermal adhesive.

The HDPE bottle contains a desiccant and features a child-resistant closure with a push-and-turn cap.

TOTALIP tablets are available in blister packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, and 100 film-coated tablets, hospital packs containing 50, 84, 100, 200 (10x20), or 500 film-coated tablets, and bottles containing 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LABORATORI GUIDOTTI S.p.A. – Via Livornese, 897 – PISA – La Vettola

Manufacturers:
A. Menarini Manufacturing Logistics and Services S.r.l.
Campo di Pile – L’Aquila (Italy)
Menarini Von Heyden GmbH
Leipziger Strasse 7-13, 01097 – Dresden (Germany)

Package leaflet: Information for the user

TOTALIP 5 mg chewable tablets, 10 mg chewable tablets, 20 mg chewable tablets, 40 mg chewable tablets

Atorvastatin
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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What TOTALIP is and what it is used for

TOTALIP belongs to a class of medicines called statins, which regulate lipid (fat) levels.
TOTALIP is used to reduce lipid levels in the blood, known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes have not been successful.
If you are at high risk of cardiovascular disease, TOTALIP may also be used to reduce this risk, even if cholesterol levels are normal. During treatment, you must continue a standard cholesterol-lowering diet.

2. What you should know before taking TOTALIP

Do not take TOTALIP

• if you are allergic to atorvastatin or to any of the other ingredients of this medicine (listed in section 6)
• if you have or have had liver disease
• if your liver function tests have shown unexplained abnormal results
• if you are a woman of childbearing age and are not using a reliable method of contraception
• if you are pregnant or planning to become pregnant
• if you are breastfeeding
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking TOTALIP:

• if you suffer from severe respiratory insufficiency
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and TOTALIP can cause serious muscle problems (rhabdomyolysis)
• if you have previously had a stroke with cerebral haemorrhage or if you have low fluid reserves in the brain due to previous strokes
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have previously experienced repeated or unexplained muscle pain, or have a personal or family history of muscle disorders
• if you have previously had muscle problems while taking other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class)
• if you regularly consume large amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years old
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4). If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with TOTALIP to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken concomitantly (see section 2 “Other medicines and TOTALIP”).

Additionally, inform your doctor or pharmacist if you have persistent muscle weakness.
Further tests and treatments may be necessary to diagnose and manage this condition.
While taking this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.

Other medicines and TOTALIP
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may alter the effect of TOTALIP, or the effect of these medicines may be altered by TOTALIP. This type of interaction may reduce the effect of one or both medicines. Alternatively, it may increase the risk or severity of adverse effects, including a condition of muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to modify the way the immune system works, e.g. cyclosporine
• Certain antibiotics or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid
• Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
• Certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines for regulating heart rhythm, e.g. digoxin, verapamil, amiodarone
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus
• Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination tipranavir/ritonavir, etc.
• Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Other medicines known to interact with TOTALIP include ezetimibe (which lowers cholesterol), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium and magnesium)
• Over-the-counter medicines: St. John’s wort
• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to resume taking TOTALIP.
  Taking TOTALIP with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

TOTALIP with food and drink
See section 3 for instructions on how to take TOTALIP. Please note the following:
Grapefruit juice
Do not drink more than one or two small glasses per day of grapefruit juice, as large quantities of grapefruit juice may alter the effects of TOTALIP.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, consult section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Do not take TOTALIP if you are pregnant or planning to become pregnant.
Do not take TOTALIP if you are of childbearing age unless you are using an effective method of contraception.
Do not take TOTALIP if you are breastfeeding.
The safety of TOTALIP during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine usually does not affect your ability to drive or use machines. However, do not drive if this medicine impairs your ability to do so. Do not use tools or machinery if your ability to use them is impaired by this medicine.

TOTALIP contains aspartame
5 mg chewable tablet:
This medicine contains 0.625 mg of aspartame in each tablet
10 mg chewable tablet:
This medicine contains 1.25 mg of aspartame in each tablet
20 mg chewable tablet:
This medicine contains 2.5 mg of aspartame in each tablet
40 mg chewable tablet:
This medicine contains 5 mg of aspartame in each tablet
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.

TOTALIP contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take TOTALIP

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must follow this diet during therapy with TOTALIP.
The usual starting dose of TOTALIP is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose until the required dose is reached. Your doctor will adjust the dosage at intervals of 4 or more weeks. The maximum dose of TOTALIP is 80 mg once daily.
TOTALIP tablets may be chewed or swallowed whole with water and can be taken at any time of day, with or without food. However, try to take the tablets at the same time each day.
Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with TOTALIP will be determined by your doctor.
If you feel that the effect of TOTALIP is too strong or too weak, consult your doctor.
If you take more TOTALIP than you should
If you accidentally take too many TOTALIP tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take TOTALIP
If you forget to take a dose, take the next dose at the scheduled time.
Do not take a double dose to make up for the missed tablet.
If you stop taking TOTALIP
If you have any doubts about using this medicine or wish to stop treatment, consult your doctor or pharmacist.

4. Possible side effects

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

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to significant breathing difficulties.
• A serious condition associated with severe peeling and swelling of the skin, skin blisters, mouth, eyes, genitals, and fever. Skin rash with reddish spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters.
• If you experience weakness, discomfort, muscle pain or tearing, or changes in urine colour (urine becoming red-brown), especially if you also feel unwell and have a high fever, this may be due to abnormal breakdown of muscle tissue (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin; it can be life-threatening and may lead to kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may indicate a liver disorder. You should contact your doctor as soon as possible.
• Lupus-like illness syndrome (including skin rash, joint problems, and effects on blood cells).

Other side effects that may occur with TOTALIP

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

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), increased creatine kinase in the blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Changes in liver function laboratory tests

Uncommon (may affect up to 1 in 100 people):

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, reduced sensitivity or tingling in the fingers of hands and feet, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain)
• Hepatitis (inflammation of the liver)
• Skin rash, skin eruption, and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (oedema), increased body temperature
• Positive urine test for white blood cells

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

• Vision disorders
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon damage

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

• Allergic reaction – symptoms may include sudden wheezing and chest pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (enlargement of the breasts in men)

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

• Persistent muscle weakness
• Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)
• Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Possible side effects reported with some statins (medicines of the same type):

• Sexual difficulties
• Depression
• Breathing difficulties including persistent cough and/or shortness of breath or fever
• Diabetes. This is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
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 TOTALIP

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister or carton after
 Exp.  . The expiry date refers to the last day of that month.
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 TOTALIP contains
The active substance in TOTALIP is atorvastatin.
Each chewable tablet contains 5 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each chewable tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each chewable tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).
Each chewable tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components are:
calcium carbonate, microcrystalline cellulose, sodium croscarmellose, polysorbate 80, hydroxypropylcellulose,
pregelatinized starch, mannitol, aspartame, sucralose, grape flavor, and magnesium stearate.

Description of the appearance of TOTALIP and contents of the pack
The TOTALIP 5 mg chewable tablets are round and white to off-white in color, with pink-violet specks. They are engraved with the number "5" on one side and "LCT" on the other.
The TOTALIP 10 mg chewable tablets are round and white to off-white in color, with pink-violet specks. They are engraved with the number "10" on one side and "LCT" on the other.
The TOTALIP 20 mg chewable tablets are round and white to off-white in color, with pink-violet specks. They are engraved with the number "20" on one side and "LCT" on the other.
The TOTALIP 40 mg chewable tablets are round and white to off-white in color, with pink-violet specks. They are engraved with the number "40" on one side and "LCT" on the other.

TOTALIP tablets are available in blister packs containing 30 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LABORATORI GUIDOTTI S.p.A. – Via Livornese, 897 – PISA – La Vettola
Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg - Mooswaldallee 1 - 79090 Freiburg, Germany