Lotivane 5/160 mg 30 tablets
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Product description
What is Amlodipine / Valsartan and its indications: Amlodipine / Valsartan tablets contain two substances called Amlodipine and Valsartan. These two substances help control high blood pressure. Amlodipine belongs to a group of substances called "calcium channel blockers." Amlodipine prevents calcium from moving into the walls of blood vessels, which prevents the vessels from constricting. Valsartan belongs to a group called "angiotensin II receptor antagonists." The body produces angiotensin II, which makes blood vessels narrow, thus increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. This means both substances help stop the constriction of blood vessels. As a result, the vessels relax and blood pressure decreases. Amlodipine / Valsartan is used to treat high blood pressure in adults whose blood pressure is not adequately controlled with Amlodipine or Valsartan alone.
What you should know before taking Amlodipine / Valsartan: Do not take Amlodipine / Valsartan if:
- You are allergic to Amlodipine or any other calcium channel blockers. This may include itching or redness of the skin or difficulty breathing.
- You are allergic to Valsartan or any other ingredients in this medicine. If you think you may be allergic, talk to your doctor before taking Amlodipine / Valsartan.
- You have serious liver problems or problems with jaundice such as cholestatic liver disease or biliary stasis.
- You are more than 3 months pregnant. (It is also better to avoid Amlodipine / Valsartan in early pregnancy).
- You have a severe drop in blood pressure (hypotension).
- You have narrowing of the aortic valve (aortic stenosis) or a heart shock (a condition where your heart cannot supply enough blood to the body).
- You have heart failure after a heart attack.
- You have diabetes or kidney impairment and are treated with an antihypertensive drug containing Aliskiren.
Precautions and warnings: Talk to your doctor before taking Amlodipine / Valsartan if:
- You are ill (vomiting or diarrhea).
- You have liver or kidney problems.
- You have had a kidney transplant or have been told you have renal artery stenosis.
- You have a condition affecting the adrenal glands called "primary aldosteronism."
- You have heart failure or a heart attack; follow your doctor’s instructions carefully for starting dose, and your doctor may also check your kidney function.
- Your doctor has told you that you have narrowing of the heart valves (called "aortic or mitral stenosis") or abnormal thickening of the heart muscle (called "hypertrophic obstructive cardiomyopathy").
- You experience swelling, especially in the face and throat, while taking other medications (including ACE inhibitors). If you experience these symptoms, stop taking Amlodipine / Valsartan and contact your doctor immediately. You should not take Amlodipine / Valsartan again.
- You are taking any of the following medications used to treat high blood pressure:
- ACE inhibitors (for example, Enalapril, Lisinopril, Ramipril), especially if you have kidney problems related to diabetes.
Children and adolescents: Amlodipine / Valsartan is not recommended for children and adolescents (under 18 years).
Other medicines and Amlodipine / Valsartan:
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Your doctor may need to change your dose and/or take other precautions.
In some cases, you may need to stop taking one of the medicines. This particularly applies to the following:
- ACE inhibitors or Aliskiren
- Diuretics (a type of medicine also called "water pills" that increase urine output)
- Lithium (a medicine used to treat some types of depression)
- Potassium-sparing diuretics, potassium supplements, and salt substitutes containing potassium, and other substances that may increase potassium levels
- Certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors. Your doctor may also check your kidney function.
- Anticonvulsants (such as Carbamazepine, Phenobarbital, Phenytoin, Fosphenytoin, Primidone)
- St. John’s Wort
- Nitroglycerin and other nitrates, or other "vasodilator" substances
- HIV/AIDS medications (such as Ritonavir, Indinavir, Nelfinavir)
- Antifungal medications (such as Ketoconazole, Itraconazole)
- Antibiotics (such as Rifampicin, Erythromycin, Clarithromycin, Telithromycin)
- Heart medications: Verapamil, Diltiazem
- Statins (used to control high cholesterol levels)
- Dantrolene (used in severe temperature regulation disorders)
- Medications used to prevent transplant rejection (Cyclosporine)
Amlodipine / Valsartan with food and drink:
Grapefruit and grapefruit juice should not be consumed by people taking Amlodipine / Valsartan because they can increase the blood levels of Amlodipine, which may lead to an unexpected increase in the blood pressure-lowering effect of Amlodipine / Valsartan.
Pregnancy and breastfeeding:
Pregnancy:
Tell your doctor if you think you (or may become) pregnant. Your doctor will usually advise you to stop taking Amlodipine / Valsartan before pregnancy or as soon as you find out you are pregnant, and will prescribe another medication instead. Amlodipine / Valsartan should not be used in early pregnancy (first three months), and should not be taken after more than 3 months of pregnancy, as it may cause serious harm to your baby if used after the third month.
Breastfeeding:
Tell your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that Amlodipine passes into breast milk in small amounts. Amlodipine / Valsartan is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is a newborn or premature.
Driving and using machines:
This medication may cause dizziness and impair your ability to concentrate. Therefore, if you are unsure how this medication affects you, do not drive or operate machinery or engage in activities that require focus.
How to take Amlodipine / Valsartan:
The usual dose of Amlodipine / Valsartan is one tablet per day.
It is preferable to take your medication at the same time each day.
Swallow the tablets with a glass of water.
You can take Amlodipine / Valsartan with or without food.
Do not take Amlodipine / Valsartan with grapefruit or grapefruit juice.
Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. Do not exceed the prescribed dose.
Amlodipine / Valsartan and the elderly (65 years or older):
Your doctor should exercise caution when increasing your dose.
If you take more Amlodipine / Valsartan than you should:
If you take too many tablets of Amlodipine / Valsartan, or if someone else takes your tablets, seek medical advice immediately.
If you forget to take Amlodipine / Valsartan:
Take the missed dose as soon as you remember. Then take your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a missed one.
If you stop taking Amlodipine / Valsartan:
Stopping treatment may worsen your condition. Do not stop taking your medication unless your doctor tells you to.
Possible side effects:
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some side effects can be serious and require immediate medical attention:
A few patients have experienced these serious side effects (which may affect up to 1 in 1000 people).
In case of any of the following, contact your doctor immediately:
- Allergic reaction with symptoms such as rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (fainting, dizziness).
Other possible side effects of Amlodipine / Valsartan:
Common (may affect up to 1 in 10 people):
- Flu, nasal congestion, sore throat, discomfort swallowing; headache; swelling of arms, hands, legs, ankles, or feet; fatigue; weakness; redness and warmth in the face and/or neck.
Uncommon (may affect up to 1 in 100 people):
- Dizziness; nausea and abdominal pain; dry mouth; drowsiness; tingling or numbness in hands or feet; rapid heartbeat including palpitations; dizziness when standing; cough; diarrhea; constipation; skin rash and redness; joint swelling and back pain; joint pain.
Reported side effects with Amlodipine or Valsartan alone, or more frequently with Amlodipine / Valsartan:
Seek medical attention immediately if you experience any of the following very rare severe side effects after taking this medicine:
- Sudden wheezing, chest pain, shortness of breath or difficulty breathing; swelling of eyelids, face, or lips; swelling of the tongue and throat causing severe breathing difficulty; severe skin reactions including severe rash, hives, skin redness all over the body, intense itching, ulcers, peeling, skin swelling, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.
- Heart attack, irregular heartbeat; pancreatitis causing severe abdominal and back pain accompanied by feeling very unwell.
Common (may affect up to 1 in 10 people):
- Dizziness and drowsiness; palpitations (awareness of your heartbeat); redness, ankle swelling (edema); stomach pain, nausea.
Uncommon (may affect up to 1 in 100 people):
- Mood changes, anxiety, depression, insomnia, tremors, taste disturbances, fainting, loss of pain sensation; visual disturbances, ringing in the ears; low blood pressure; sneezing/running nose caused by nasal inflammation (rhinitis); indigestion and vomiting; hair loss, increased sweating, skin itching, skin color changes; urinary disturbances, increased need to urinate at night, increased frequency of urination; inability to achieve an erection or discomfort or breast enlargement in men, pain, feeling unwell, muscle pain, cramps; weight gain or loss.
Decreased red blood cells, fever, sore throat or mouth ulcers due to infections; spontaneous bleeding or bruising; high potassium levels in the blood; abnormal liver test results; severe kidney impairment and decreased kidney function; swelling mainly in the face and throat; muscle pain; skin rash, purple or red spots; fever; itching; allergic reactions; skin ulcers (a sign of a condition called epidermal blistering disease).
How to store Amlodipine / Valsartan:
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiration date printed on the packaging.
Do not store above 30°C.
Store in the original container to protect from moisture.
Product details:
Brand: Lotifan
Quantity: 30 tablets
Product form: Tablets
Product type: Tablets

