Torvazin Plus 10 mg/10 mg. 30 capsules

What Torvasin Plus is and what it is used for
Torvasin Plus contains two different active ingredients in one capsule. One of the active ingredients is atorvastatin, from the group of so-called "statins" and the other active ingredient is ezetimibe.

Torvasin Plus is a medicine used in adults to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. It also increases levels of "good" cholesterol (HDL cholesterol). The action of this drug is expressed in lowering cholesterol in two ways: it reduces the cholesterol that is absorbed in the digestive tract and the cholesterol that is produced in the body.

For most people, high cholesterol doesn't affect how they feel because it doesn't cause symptoms. However, if left untreated, fatty deposits can form on the walls of the blood vessels and thus narrow them.

Sometimes narrowed blood vessels can become blocked, which can cut off blood supply to the heart and brain and lead to a heart attack or stroke, by lowering your cholesterol levels you can reduce your risk of heart attack, stroke or related health problems.

This medicinal product is used in patients whose cholesterol levels cannot be controlled with a cholesterol-lowering diet alone. You should continue your cholesterol-lowering diet while taking this medicine.

Your doctor may prescribe Torvasin Plus if you are already taking atorvastatin and ezetimibe at the same dose.

This medicinal product does not help with weight loss.

2. What you need to know before taking Torvazin Plus
Do not take Torvazin Plus:
if you are allergic to atorvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6)
if you have or have ever had a disease that affects the liver
if you have had unexplained abnormalities in liver function blood tests
if you are a woman of childbearing potential and are not using reliable contraceptives
if you are pregnant or trying to become pregnant
if you are breastfeeding
if you are taking the combination glecaprevir/pibrentasvir to treat hepatitis C
Warnings and precautions
Talk to your doctor or pharmacist before taking Torvazin Plus:
if you have a severe form of respiratory failure,
if you are taking or have taken in the last 7 days a medicine called fusidic acid (against a bacterial infection), by mouth or by injection. The combination of fusidic acid and this medicine can cause serious muscle problems (rhabdomyolysis). (See paragraph "Other medicines and Torvazin Plus")
if you have had a stroke with bleeding in the brain or have had small 'pockets' in your brain from previous strokes,
if you have kidney problems,
if you have low thyroid function (hypothyroidism),
if you have ever had recurrent or unexplained muscle pain, a personal or family history of muscle problems,
if you have previously had muscle problems during treatment with another lipid-lowering medicine (for example, other "statins" or "fibrates")
if you regularly drink large amounts of alcohol,
if you have had liver disease,
if over 70 years of age.
Contact your doctor as soon as possible if you have unexplained pain, tenderness or muscle weakness while taking Torvasin Plus, as in rare cases muscle problems can be serious, including muscle breakdown leading to kidney failure. Atorvastatin is known to cause muscle problems, and cases of muscle problems have been reported with ezetimibe.

Also tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to diagnose and treat it.

While you are taking this medicine, your doctor will monitor your condition regularly if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high blood sugar and fat levels, if you are overweight and have high blood pressure.

Tell your doctor about all your medical problems, including allergies.

The combined use of Torvasin Plus and fibrates (medicines to lower cholesterol) should be avoided, as the use of this medicinal product in combination with fibrates has not been studied.

Children and adolescents
The use of Torvazin Plus is not recommended for children and adolescents under 18 years of age.

Other drugs and Torvazin Plus
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines can change the effect of Torvazin Plus or their effect can be changed by Torvazin Plus. This type of interaction could reduce the effectiveness of one or both drugs. Conversely, it could increase the risk or burden
Letermovir, a medicine that helps prevent cytomegalovirus disease
Medicines used to treat HIV infection, eg ritocavir, lopinavir, atazanavir, indinavir, darunavir, efavirenz, fosamprevir, delavirdine, the tipranavir/ritonavir combination, etc.
Some medicines used to treat hepatitis C (inflammation of the liver), eg telaprevir, boceprevir and the combination elbasvir/grazoprevir, ledipasvir/sofosbuvir.
Fusidic acid. If you need to take fusidic acid to treat a bacterial infection, you will need to stop this medicine temporarily. Your doctor will tell you when it is safe to resume taking Torvazin Plus. Taking this medicinal product with fusidic acid may rarely cause weakness, tenderness or pain in the muscles (rhabdomyolysis). See more information about rhabdomyolysis in section 4.
Other drugs known to interact with this medicinal product.
warfarin, phenprocoumon, acenocoumarol or fluindione (medicines to prevent blood clotting)
oral contraceptives (medicines to prevent pregnancy)
stiripentol (anticonvulsant medicine for epilepsy)
cimetidine (medicine for heartburn and peptic ulcer)
phenazone (pain reliever)
colchicine (to treat gout)
antacids (indigestion products that contain aluminum or magnesium)
St. John's wort (medicine to treat depression)
Torvazin Plus with food and alcohol
See section 3 for instructions on how to take this medicinal product. Please note the following:

Grapefruit juice
Do not take more than one or two glasses of grapefruit juice per day, as large amounts of this juice may change how this medicine works.

Alcohol
Avoid drinking too much alcohol while taking this medicine. See more details in the section "Warnings and precautions" in point 2.

Pregnancy and breastfeeding
Do not take Torvazin Plus if you are pregnant, planning to become pregnant or think you may be pregnant.

Women of childbearing potential should not take this medicinal product unless they are using reliable contraception. If you become pregnant while taking this medicine, stop taking it immediately and tell your doctor.

Do not take Torvazin Plus if you are breast-feeding.

The safety of this medicinal product during pregnancy and breastfeeding has not been proven. If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Torvazin Plus is not expected to affect your ability to drive or use machines. However, it should be borne in mind that some people feel dizzy after taking this medicinal product. If you feel dizzy, consult your doctor before driving or using machines.

This medicinal product contains sucrose and sodium
Torvasin Plus contains sucrose. If your doctor has told you that you have an intolerance to some types of sugars, consult your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. essentially sodium free.

3. How to take Torvazin Plus
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

You should continue a low-cholesterol diet while taking this medicine.

The recommended daily dose for adults is one capsule of the corresponding concentration. Take Torvazin Plus once a day.

The capsules can be taken at any time of the day, with or without food. However, try to take your capsule at the same time each day. Swallow each capsule whole with water.

This medicinal product is not suitable for initiation of treatment. The treatment is started or, if necessary, the dose is adjusted only with a separate intake of the active ingredients, or only after establishing the appropriate doses is it possible to switch to Torvasin Plus, in the corresponding concentration.

If your doctor has prescribed Torvasin Plus together with another cholesterol-lowering medicine that contains the active ingredient cholestyramine, or another medicine that contains bile acid sequestrants, you must take this medicinal product at least 2 hours before or 4 hours after taking of the bile acid sequestrant.

If you have taken more than the required dose of Torvazin Plus
If you accidentally take too many capsules (more than the recommended daily dose), consult your doctor or the nearest hospital.

If you forget to take Torvazin Plus
If you miss a dose, take the next scheduled dose at the appropriate time. Do not take a double dose to make up for a missed dose.

If you have stopped taking Torvazin Plus
Consult your doctor if you wish to stop taking Torv
Uncommon (may affect up to 1 in 100 people):
low blood sugar levels
weight gain
decrease or loss of appetite
nightmares
insomnia
dizziness
numbness or tingling in fingers and toes decreased sensitivity to pain or touch impaired sense of taste memory loss
blurred vision
noise in the ears
heat waves
high blood pressure
cough
vomiting
hiccups
inflammation of the pancreas causing severe pain in the stomach that can reach the back
acids
dry mouth
inflammation of the stomach (gastritis)
inflammation of the liver (hepatitis)
urticaria
itching
skin rash
hair loss
neck pain
muscle weakness
fatigue (feeling of general weakness)
asthenia (lack of energy and strength)
chest pain
pain
sweating, especially of the palms and soles
fever
presence of white blood cells in urine tests
increased level of liver enzyme in the blood
Rare (may affect up to 1 in 1,000 people):
reduced number of platelets in the blood, which increases the risk of clotting/bleeding (thrombocytopenia)
nerve damage in the legs and arms (eg, cramp)
visual impairment
cholestasis (yellowing of the skin and the whites of the eyes)
Raised reddish rash, sometimes with target-like lesions (erythema multiforme)
muscle disease with muscle weakness (myopathy)
muscle inflammation
tendon damage
Very rare (may affect up to 1 in 10,000 people):
hearing loss
liver failure
male breast enlargement (gynaecomastia)
Not known (frequency cannot be estimated from the available data):
depression
out of breath
gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)
persistent muscle weakness (immune-mediated necrotizing myopathy)
Possible side effects reported with some statins
sexual difficulties
breathing problems, including a persistent cough and/or shortness of breath, or fever
diabetes. This is more likely to happen if you have high blood sugar and blood fat levels, if you are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
5. How to store Torvazin Plus
Keep out of the reach of children.

Store below 30°C, in the original packaging to protect from moisture.

Do not use this medicine after the expiry date (EXP) which is stated on the pack. The expiration date corresponds to the last day of the specified month.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

b. Package contents and additional information
What Torvazin Plus contains
The active ingredients are atorvastatin (as atorvastatin calcium trihydrate) and ezetimibe. Each capsule contains 10 mg, 20 mg or 40 mg of atorvastatin and 10 mg of ezetimibe.
The other ingredients are:
Core: calcium carbonate, hydroxypropyl cellulose, polysorbate 80, croscarmellose sodium (SD711), sugar spheres (contain sucrose and corn starch), talc, mannitol, microcrystalline cellulose, low substituted hydroxypropyl cellulose (L-HPC B1), povidone K.-25 , sodium lauryl sulfate, magnesium stearate.
Capsule shell:
Torvasin Plus 10 mg/10 mg hard capsules:

Capsule cap: titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), gelatin

Torvasin Plus 20 mg/10 mg hard capsules:

Capsule cap: titanium dioxide (E171), red iron oxide (E172), gelatin

Torvasin Plus 40 mg/10 mg hard capsules:

Capsule cap: titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), gelatin.

Capsule body for all concentrations: titanium dioxide (E 171), yellow iron oxide (E 172), gelatin
What Torvazin Plus looks like and what the package contains
Torvasin Plus 10 mg/10 mg hard capsules: Self-closing, hard gelatin capsule size 0, unmarked, with a caramel-colored cap and yellow body, filled with pellets and one tablet.

Torvasin Plus 20 mg/10 mg hard capsules: Size 0 self-closing hard gelatin capsule, unmarked, with red-brown cap and yellow body, filled with pellets and one tablet.

Torvasin Plus 40 mg/10 mg hard capsules: Self-closing, hard gelatin capsule size 0, unmarked, with dark brown cap and yellow body, filled with pellets and one tablet.

Filling the capsules:
Atorvastatin Immediate-Release Pellets: Spherical Pellets Ezetimibe 10 mg tablet: one round, flat, bevelled-edge tablet, engraved with a stylized symbol "E" on one side and engraved with "612" on the other side.

30,60, 70,80, 90,100 or 120 hard capsules in an OPA/A1/PVC//A1 blister placed in a folded cardboard box.

Not all types of packaging can be put on sale.

 

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