Thervan Plus 10 mg/40 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Thervan Plus 10 mg/20 mg film-coated tablets EFG
Thervan Plus 10 mg/40 mg film-coated tablets EFG
Thervan Plus 10 mg/80 mg film-coated tablets EFG
ezetimibe/atorvastatin
Read all of this leaflet carefully before you start 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Thervan Plus is and what it is used for
- What you need to know before taking Thervan Plus
- How to take Thervan Plus
- Possible side effects
- How to store Thervan Plus
- Contents of the pack and other information
1. What Thervan Plus is and what it is used for
Thervan Plus is a medication that lowers high levels of cholesterol. This medicine contains ezetimibe and atorvastatin.
Ezetimibe/atorvastatin is used in adults to lower total cholesterol levels, "bad" cholesterol (LDL cholesterol), and blood fat substances called triglycerides. In addition, ezetimibe/atorvastatin increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe/atorvastatin works to reduce cholesterol in two ways: by decreasing cholesterol absorbed in the digestive tract and by reducing cholesterol produced by the body itself.
Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol consists mainly of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this plaque buildup can narrow the arteries. This narrowing may slow down or block blood flow to vital organs such as the heart and brain. Such disruption in blood flow may trigger a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from accumulating in the arteries and protects against heart disease.
Triglycerides are another type of fat in your blood that may increase the risk of heart disease.
Ezetimibe/atorvastatin is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.
Ezetimibe/atorvastatin is used, together with a cholesterol-lowering diet, if you have:
? high blood levels of cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]) or high blood levels of fatty substances (mixed hyperlipidemia):
? that are not well controlled with a statin alone
? who have previously been treated with a statin and ezetimibe in separate tablets
? a hereditary condition (homozygous familial hypercholesterolemia), which increases blood cholesterol levels. You may also receive other treatments.
? heart disease; ezetimibe/atorvastatin reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.
Ezetimibe/atorvastatin does not help you lose weight.
2. What you need to know before taking Thervan Plus
Do not take Thervan Plus
? if you are allergic to ezetimibe, atorvastatin, or any of the other ingredients of this medicine (listed in section 6),
? if you have or have ever had liver disease,
? if you have had unexplained abnormal results in blood tests assessing liver function,
? if you are a woman of childbearing potential and are not using reliable contraceptive methods,
? if you are pregnant, trying to become pregnant, or breastfeeding,
? if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.
Warnings and precautions
Consult your doctor or pharmacist before starting ezetimibe/atorvastatin
? if you have previously had a stroke with intracranial haemorrhage, or have small accumulations of fluid in the brain due to prior strokes,
? if you have kidney problems,
? if your thyroid gland is underactive (hypothyroidism),
? if you have had recurrent or unexplained muscle pain or discomfort, or have a personal or family history of muscle disorders,
? if you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g., other medicines containing "statins" or "fibrates"),
? if you regularly consume large amounts of alcohol,
? if you have a history of liver disease,
? if you are over 70 years of age,
? if your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine,
? if you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by mouth or injection. The combination of fusidic acid and ezetimibe/atorvastatin may cause serious muscle problems (rhabdomyolysis),
? if you have or have had myasthenia (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or weakness while taking ezetimibe/atorvastatin. This is because, although rarely, muscle problems can be serious and may include muscle breakdown leading to kidney damage. Atorvastatin is known to cause muscle problems, and such problems have also been reported with ezetimibe.
Also inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.
Consult your doctor or pharmacist before starting ezetimibe/atorvastatin:
- if you have severe respiratory failure.
If you are in any of the above situations (or are unsure), consult your doctor before starting ezetimibe/atorvastatin, as your doctor may need to perform blood tests before and possibly during treatment to assess your risk of developing muscle-related side 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 “Taking Thervan Plus with other medicines”).
While taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk is higher if you have high levels of sugar and fat in your blood, are overweight, or have high blood pressure.
Inform your doctor about all your medical conditions, including allergies.
The combined use of ezetimibe/atorvastatin and fibrates (certain medicines used to lower cholesterol) should be avoided, as the combination of ezetimibe/atorvastatin with fibrates has not been studied.
Children
Ezetimibe/atorvastatin is not recommended for use in children and adolescents.
Other medicines and Thervan Plus
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.
Some medicines may alter the effect of ezetimibe/atorvastatin or their effects may be altered by ezetimibe/atorvastatin (see section 3). Such interactions could reduce the effectiveness of one or both medicines. They could also increase the risk or severity of side effects, including a serious condition involving muscle breakdown known as “rhabdomyolysis,” described in section 4:
? cyclosporine (a medicine often used in transplant patients),
? erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (medicines used to treat bacterial infections),
? ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines used to treat fungal infections),
? gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, cholestyramine (medicines used to regulate lipid levels),
? certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem,
? digoxin, verapamil, amiodarone (medicines that regulate heart rhythm),
? medicines used in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),
? some medicines used in the treatment of hepatitis C, e.g., telaprevir, boceprevir, and the combination of elbasvir/grazoprevir,
? daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).
** If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when you can restart treatment with ezetimibe/atorvastatin. Using ezetimibe/atorvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4
? Other medicines known to interact with ezetimibe/atorvastatin
? oral contraceptives (medicines that prevent pregnancy),
? stiripentol (an anticonvulsant medicine used to treat epilepsy),
? cimetidine (a medicine used for stomach acidity and peptic ulcers),
? phenazone (an analgesic),
? antacids (products for treating indigestion containing aluminium or magnesium),
? warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines that prevent blood clots),
? colchicine (used to treat gout),
? St. John’s wort (a herbal remedy used to treat depression).
Taking Thervan Plus with food and alcohol
See section 3 for instructions on how to take ezetimibe/atorvastatin. Please note the following:
Grapefruit juice
Do 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 this medicine.
Alcohol
Avoid consuming excessive amounts of alcohol while taking this medicine. For further details, see section 2 “Warnings and precautions”.
Pregnancy and breastfeeding
Do not take ezetimibe/atorvastatin if you are pregnant, trying to become pregnant, or think you may be pregnant. Do not take ezetimibe/atorvastatin if you could become pregnant unless you are using reliable contraceptive methods. If you become pregnant while taking ezetimibe/atorvastatin, stop taking it immediately and inform your doctor.
Do not take ezetimibe/atorvastatin if you are breastfeeding.
The safety of ezetimibe/atorvastatin during pregnancy and breastfeeding has not been established.
Consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Ezetimibe/atorvastatin is not expected to affect your ability to drive or operate machinery. However, you should be aware that some people may experience dizziness after taking ezetimibe/atorvastatin.
Thervan Plus 10 mg/20 mg and 10 mg/40 mg contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Thervan Plus contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; essentially “sodium-free”.
3. How to take Thervan Plus
Follow exactly the instructions for use of this medicine as given by your doctor. Your doctor will determine the appropriate tablet strength for you, depending on your current treatment and your individual risk situation. If in doubt, consult your doctor or pharmacist again.
? Before starting ezetimibe/atorvastatin, you should already be on a cholesterol-lowering diet.
? You must continue this cholesterol-lowering diet while taking ezetimibe/atorvastatin.
How much to take
The recommended dose is one ezetimibe/atorvastatin tablet once daily, taken orally.
Method of administration
Take ezetimibe/atorvastatin at any time of the day. It may be taken with or without food.
If your doctor has prescribed ezetimibe/atorvastatin together with cholestyramine or any other bile acid sequestrant (medicines that reduce cholesterol levels), you must take ezetimibe/atorvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Thervan Plus than you should
Consult your doctor or pharmacist.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Thervan Plus
Do not take a double dose; on the following day, take your usual dose of ezetimibe/atorvastatin at the usual time.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you experience any of the following serious adverse effects or symptoms, stop taking your tablets immediately and contact your doctor right away or go to the nearest hospital emergency department.
? severe allergic reactions causing swelling of the face, tongue, and throat, which may cause severe difficulty breathing
? a serious illness characterized by severe skin peeling and inflammation, blistering of the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, especially on the palms of the hands or soles of the feet, which may progress to blistering
? muscle weakness, tenderness, pain, or muscle breakdown, or change in urine color to red-brown, and especially if occurring together with a feeling of malaise or high temperature, which may be due to abnormal muscle destruction that can be potentially life-threatening and lead to kidney problems
? lupus-like syndrome (including rash, joint disorders, and effects on blood cells)
Consult your doctor as soon as possible if you experience problems associated with unexpected or unusual bleeding or bruising, as this may indicate liver disease.
The following adverse effects have been reported as common (may affect up to 1 in 10 patients):
? diarrhoea,
? muscle pain.
The following adverse effects have been reported as uncommon (may affect up to 1 in 100 patients):
? influenza-like illness,
? depression; sleep problems; sleep disorder,
? dizziness; headache; tingling sensation,
? slow heart rate,
? hot flushes,
? choking sensations,
? abdominal pain; bloating; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; malaise,
? acne; hives,
? joint pain; back pain; leg cramps; muscle fatigue, spasms or weakness; pain in arms and legs,
? unusual weakness; feeling of tiredness or malaise; swelling, especially in the ankles (oedema),
? increase in certain liver or muscle function tests (CK) in laboratory blood tests,
? weight gain.
The following adverse effects have been reported with unknown frequency (frequency cannot be estimated from available data):
? myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects 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 difficulty breathing.
Additionally, the following adverse effects have been reported in people taking ezetimibe/atorvastatin, ezetimibe, or atorvastatin tablets:
? allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing (requiring immediate medical treatment),
? red skin rash, sometimes target-shaped,
? liver problems,
? cough,
? acid reflux,
? decreased appetite; loss of appetite,
? high blood pressure,
? skin rash and itching; allergic reactions including skin rash and hives,
? tendon injury,
? gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea or vomiting),
? inflammation of the pancreas, often accompanied by severe abdominal pain,
? decreased blood cell count, which may lead to bruising/bleeding (thrombocytopenia),
? nasal inflammation; nosebleeds,
? neck pain; chest pain; sore throat,
? increased or decreased blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels),
? nightmares,
? numbness or tingling in fingers and toes,
? reduced sensitivity to pain or touch,
? altered sense of taste; dry mouth,
? memory loss,
? ringing in the ears and/or head; hearing loss,
? vomiting,
? belching,
? hair loss,
? high temperature,
? presence of white blood cells in urine tests,
? blurred vision; visual disturbances,
? gynaecomastia (enlargement of breast tissue in men).
Possible adverse effects reported with some statins
? sexual dysfunction,
? depression,
? respiratory problems, including persistent cough and/or choking sensations or fever,
? diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
? persistent muscle pain, tenderness or weakness, and especially if occurring together with a feeling of malaise or high temperature, which may not resolve after stopping treatment with ezetimibe/atorvastatin (frequency not known).
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Thervan Plus
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Thervan Plus
The active substances are ezetimibe and atorvastatin. Each film-coated tablet contains 10 mg of ezetimibe and 20 mg, 40 mg or 80 mg of atorvastatin (as atorvastatin calcium trihydrate).
The other components are: microcrystalline cellulose, mannitol, calcium carbonate, sodium croscarmellose, hydroxypropylcellulose, polysorbate 80, yellow iron oxide (E-172), magnesium stearate, povidone and sodium lauryl sulfate.
The tablet coating contains: monohydrate lactose (Thervan Plus 10 mg/20 mg and 10 mg/40 mg), hypromellose (E-464), titanium dioxide (E-171), macrogol; and talc and yellow iron oxide (E-172) (Thervan Plus 10 mg/80 mg).
Appearance of the product and contents of the container
Thervan Plus 10 mg/20 mg tablets are film-coated, oval-shaped, biconvex, white tablets with an approximate size of 11.6 x 7.1 mm.
Thervan Plus 10 mg/40 mg tablets are film-coated, capsule-shaped, biconvex, white tablets with an approximate size of 16.1 x 6.1 mm.
Thervan Plus 10 mg/80 mg tablets are film-coated, oblong, biconvex, yellow tablets with an approximate size of 19.1 x 7.6 mm.
The tablets are available in blister packs made of OPA/Al/PVC//Al, in pack sizes of 30 tablets.
Marketing Authorization Holder
Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain
Manufacturer
ELPEN Pharmaceutical Co. Inc.
Marathonos Ave. 95, Pikermi Attiki, 19009
Greece
or
ELPEN Pharmaceutical Co. Inc.
Zapani, Block 1048, Keratea, 190 01
Greece
Date of the most recent review of this summary: January 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).