Melemib

Package leaflet: Information for the user

Melemib 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Atorvastatin
Generic medicine
Read this leaflet carefully before you start using this medicine.

• 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. Never give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What Melemib is and what it is used for
2. What you need to know before taking Melemib
3. How to take Melemib
4. Possible side effects
5. How to store Melemib
6. Further information

1. What Melemib is and what it is used for

Melemib belongs to a class of medicines called statins, which regulate lipid (fat) levels.
Melemib is used to lower 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 risk of cardiovascular disease, Melemib may also be used to reduce this risk even if your cholesterol levels are normal.
You must continue a cholesterol-lowering standard diet during treatment.

2. What you need to know before taking Melemib

Do not use Melemib

• 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 using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

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

• 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) by mouth or injection. The combination of fusidic acid and Melemib 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 problems
• 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 Melemib 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 Melemib”).
Also, 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 Melemib
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Some medicines can alter the effect of Melemib, or the effect of these medicines can be altered by Melemib.
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 involving muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines that 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 combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Other medicines known to interact with Melemib 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 or magnesium)
• Non-prescription medicines: St. John’s wort
• If you need to take fusidic acid orally to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart Melemib. Taking Melemib with fusidic acid may rarely

cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on
rhabdomyolysis, see section 4.

• Daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteria in the blood)

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

Pregnancy and breastfeeding
Do not take Melemib if you are pregnant or planning to become pregnant.
Do not take Melemib if you are of childbearing age unless you are using an effective method of contraception.
Do not take Melemib if you are breastfeeding.
The safety of Melemib 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 machinery if your ability to operate them is impaired by this medicine.

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

3. How to take Melemib

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must follow this diet throughout your treatment with Melemib.
The usual starting dose of Melemib 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 Melemib is 80 mg once daily.
Melemib tablets must be 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 Melemib will be determined by your doctor.
If you feel that the effect of Melemib is too strong or too weak, talk to your doctor.
If you take more Melemib than you should
If you accidentally take too many Melemib tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take Melemib
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 forgotten dose.
If you stop taking Melemib
If you have any questions about using this medicine or if you wish to stop treatment, speak to 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 right away 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 muscle weakness, tenderness, pain, or breakdown, or notice changes in the colour of your urine (e.g. red-brown colour), especially if you also feel unwell or have a high fever, this may be due to abnormal muscle deterioration (rhabdomyolysis).
• Abnormal muscle deterioration does not always resolve, even after stopping atorvastatin. It may be life-threatening and can lead to kidney problems.

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

• unexpected or unusual bleeding or bruising, which may suggest a liver disorder. You should contact your doctor as soon as possible.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

Other possible side effects that may occur with Melemib:
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 fingers and toes, reduced sensitivity to pain or touch, taste disturbances, 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, urticaria, 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
• skin rash which may appear on the skin or mouth ulcers (drug-induced lichenoid reaction)
• purplish skin lesions (signs of blood vessel inflammation, vasculitis)

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, which in some cases may affect the muscles used for breathing).
• ocular myasthenia (a disease causing weakness of the eye muscles).

Contact your doctor 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.
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, 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, 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 Melemib

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Other Information

What Melemib contains

• The active substance is atorvastatin as atorvastatin calcium. Each film-coated tablet of 10 mg, 20 mg or 40 mg contains 10 mg, 20 mg or 40 mg of atorvastatin, respectively.
• The other excipients are: Tablet core: mannitol, microcrystalline cellulose, crospovidone, anhydrous sodium carbonate, povidone, methionine, magnesium stearate. Film coating: hypromellose 6 cP, titanium dioxide (E171), macrogol 6000, talc.

Description of the appearance of Melemib and packaging contents

Film-coated tablets
10 mg: White, oval, biconvex film-coated tablet, 4.9 x 9.1 mm, marked “10” on one side and “A” on the other.
20 mg: White, oval, biconvex film-coated tablet, 6.2 x 11.5 mm, marked “20” on one side and “A” on the other.
40 mg: White, oval, biconvex film-coated tablet, 7.8 x 14.5 mm, marked “40” on one side and “A” on the other.
Packaging:
Melemib 10 mg film-coated tablets: 30 tablets in blister packs.
Melemib 20 mg film-coated tablets: 30 tablets in blister packs.
Melemib 40 mg film-coated tablets: 30 tablets in blister packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Genetic S.p.A.
Via G. Della Monica, 26 - 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A.
Contrada Canfora – 84084 Fisciano (SA)
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