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Teva Simvastatin

Teva Simvastatin

(simvastatin)

Simvastatin belongs to the group of medications known as HMG CoA reductase inhibitors ("statins"). It is used in addition to diet and exercise to lower cholesterol levels.

Available form

Dosage

Tablet

5MG, 10MG, 20MG, 40MG, 80MG

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Teva Simvastatin information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

Before or when starting simvastatin, you should be placed on a cholesterol-lowering diet. If appropriate, a health care professional will discuss an individualized program of weight control and physical exercise with you.

The starting dose of Teva Simvastatin depends on your medical conditions and other medications you are taking, and can range from 5 mg to 40 mg taken once daily in the evening. The maximum recommended daily dose is 80 mg, which may be used for some people who have been taking this amount for a long time with no muscle problems or people at high risk of heart disease who have problems taking other "statins." The maximum daily dose may be lower for people taking certain medications.

The maximum dose for children and adolescents 10 to 17 years of age with inherited cholesterol disorders is 40 mg.

For best results in lowering your cholesterol, it is very important that you closely follow the diet suggested by your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Teva Simvastatin exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Teva Simvastatin at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Teva Simvastatin. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking Teva Simvastatin. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

abdominal pain
Constipation
Diarrhea
difficulty getting/maintaining an erection (men)
gas
headache
nausea
nightmares
skin rash
trouble sleeping
upset stomach

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

blurred vision
breathing problems (e.g., shortness of breath, persistent cough)
confusion
memory loss
signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
symptoms of liver damage (e.g., yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting, or itching)
symptoms of muscle damage (e.g., unexplained muscle pain, tenderness, or weakness, or brown or discoloured urine – especially if you also have a Fever or a general feeling of being unwell)

Stop taking the medication and seek medical attention immediately if any of the following occur:

severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
symptoms of a serious allergic reaction (e.g., swelling of the face or throat, Hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Teva Simvastatin.

5 mg
Each buff, biconvex, film-coated, shield-shaped tablet, engraved with "5" on one side and "N" on the other side, contains simvastatin 5 mg. Nonmedicinal ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Tablet coating: hypromellose, iron oxide yellow, polyethylene glycol, polysorbate 80, and titanium dioxide

10 mg
Each peach-coloured, biconvex, film-coated, shield-shaped tablet, engraved with "10" on one side and "N" on the other side, contains simvastatin 10 mg. Nonmedicinal ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Tablet coating: hypromellose, iron oxide red, polydextrose, polyethylene glycol, titanium dioxide, and triacetin/glycerol triacetate.

20 mg
Each tan, biconvex, film-coated, shield-shaped tablet, engraved with "20" on one side and "N" on the other side, contains simvastatin 20 mg. Nonmedicinal ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Tablet coating: hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin/glycerol triacetate.

40 mg
Each brick-red, biconvex, film-coated, shield-shaped tablet, engraved with "40" on one side and "N" on the other side, contains simvastatin 40 mg. Nonmedicinal ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Tablet coating: hypromellose, iron oxide yellow, polyethylene glycol, polysorbate 80, and titanium dioxide.

80 mg
Each brick-red, biconvex, film-coated, caplet-shaped tablet, engraved with "80" on one side and "N" on the other side, contains simvastatin 80 mg. Nonmedicinal ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Tablet coating: hypromellose, iron oxide yellow, polyethylene glycol, polysorbate 80 and titanium dioxide.

There may be an interaction between simvastatin and any of the following:

Amiodarone
Amlodipine
antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
Aprepitant
asunaprevir
"azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
Bicalutamide
Bezafibrate
Bosentan
calcium channel blockers (e.g., amlodipine, Diltiazem, Nifedipine, Verapamil)
Carbamazepine
cobicistat
Colchicine
conivaptan
Crizotinib
cyclosporine
Cyproterone
dabigatran
Dabrafenib
daclatasvir
danazol
Dasatinib
Deferasirox
Dronedarone
elbasvir
Eltrombopag
Enzalutamide
fenofibrate
gemfibrozil
grapefruit juice
grazoprevir
Haloperidol
HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
Lomitapide
macrolide antibiotics (e.g., clarithromycin, erythromycin)
mifepristone
Mitotane
Metronidazole
Modafinil
nefazodone
niacin (nicotinic acid)
niacinamide
Phenobarbital
Phenytoin
primidone
proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
quinine
red yeast rice
rifabutin
rifampin
Risperidone
St. John's wort
Sertraline
Sildenafil
siltuximab
simeprevir
Sitagliptin
Teriflunomide
Ticagrelor
Tocilizumab
trabectedin
tyrosine kinase inhibitors (e.g., dasatinib, imatinib, Nilotinib, Sunitinib)
Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,
change one of the medications to another,
change how you are taking one or both of the medications, or
leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Teva Simvastatin. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Teva Simvastatin.

Alcohol: Consumption of alcohol can increase the risk of liver damage when taking simvastatin. If you regularly drink more than 3 drinks of alcohol daily, the risk is further increased and you should be closely monitored by your doctor while taking Teva Simvastatin.

Diabetes: Simvastatin, like other medications in this family, may cause a loss of control of blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Simvastatin, and whether any special monitoring is needed.

Grapefruit juice: Don't drink grapefruit juice while taking Teva Simvastatin, as it can increase the amount of simvastatin in the blood and increase the risk of serious side effects.

Kidney problems: People with decreased kidney function should discuss with their doctor how Teva Simvastatin may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Teva Simvastatin, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Teva Simvastatin to build up in the body, causing side effects. If you have a history of liver disease, discuss with your doctor how Teva Simvastatin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Simvastatin, and whether any special monitoring is needed.

Laboratory tests show signs of harmful effects to the liver that may occur for a small percentage of people who take simvastatin. When Teva Simvastatin is stopped, liver function usually slowly returns to normal. Your doctor will perform regular tests to check your liver function.

Teva Simvastatin should not be used by people with active liver disease or by people whose liver function tests are higher than normal.

Muscle effects: In rare cases, serious muscle pain, cramps, and weakness have been associated with the use of statin medications (i.e., cholesterol-lowering medications whose names end in "statin," such as Atorvastatin, Fluvastatin, Lovastatin, Pravastatin, Rosuvastatin, or simvastatin), especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:

are 65 years of age or older
are female
are taking other cholesterol-lowering medications such as fibrates (e.g., gemfibrozil, Fenofibrate) or Niacin
do excessive physical exercise
have a family history of muscular disorders
have diabetes
have had any past problems with the muscles (pain, tenderness) after taking a statin medication
have Hypothyroidism (low Thyroid) that is not controlled with medication
have kidney or liver problems
have undergone surgery or other tissue injury
regularly drink 3 or more alcoholic drinks daily

Report any unexplained muscle pain, tenderness, weakness, or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Pregnancy: Simvastatin should not be taken during pregnancy. It may cause harm to the unborn baby. If you become pregnant, stop taking Teva Simvastatin and contact your doctor immediately.

Breast-feeding: It is not known if simvastatin passes into breast milk. If you are a breast-feeding mother and are taking Teva Simvastatin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Teva Simvastatin have not been established for children less than 10 years of age or in girls who have not started menstruating.

Seniors: If you are 65 years of age or older, you may experience more side effects. Your doctor will monitor you closely while you are taking Teva Simvastatin.

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