Losartan Potassium 100mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Losartan potassium 25 mg, 50 mg, 100 mg Film-coated Tablets (Losartan Potassium)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Losartan is and what it is used for
2. Before you take Losartan
3. How to take Losartan
4. Possible side effects
5. How to store Losartan
6. Further information
The name of your medicine is Losartan potassium 25 mg, 50 mg or 100 mg film-coated tablets. (referred to as Losartan in this leaflet)
1. WHAT LOSARTAN IS AND WHAT IT IS USED FOR
Losartan belongs to a group of medicines known as angiotensin-II receptor blockers (ARBs). Losartan can reduce blood pressure and improve the ability of the heart to pump blood.
Losartan is used:
• to treat patients with chronic heart failure when therapy with specific medicines called ACE inhibitors is not considered suitable by your doctor.
You should not be switched to losartan if your heart failure has been stabilised with an ACE inhibitor
• to lower blood pressure in people who have high blood pressure
If you have high blood pressure AND you have diabetes (treated by tablets or diet) and kidney problems THEN losartan will help protect your kidneys.
If you have high blood pressure AND you have been shown to have thickened heart muscle THEN losartan has been shown to reduce your risk of stroke.
2. BEFORE YOU TAKE LOSARTAN
Do not take Losartan:
• if you are allergic (hypersensitive) to losartan or to any of its other ingredients
• if you have severe liver problems
• if you are more than 3 months pregnant. (It is also better to avoid Losartan in early pregnancy-see pregnancy section.)
Take special care with Losartan
You must tell your doctor if you think you are (or might become) pregnant. Losartan is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
It is important to tell your doctor before taking Losartan:
• if you have ever had swelling of the face, lips, throat, and/or tongue (also known as “angioedema”)
• if you lose fluid through vomiting or diarrhoea
• if you are prescribed diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction
• if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant
• if you have liver problems
• if you have heart problems - caution is needed if you are treated with medicines known as B-blockers
• if you have ever had a stroke
• if you suffer from “primary hyperaldosteronism” (a hormone imbalance)
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.
Take particular care if you are taking the following medicines while under treatment with Losartan:
• Other blood pressure lowering medicines as they may additionally reduce your blood pressure. This list of medicines includes baclofen, amifostine and medicines used for mental health such as amitriptyline and chlorpromazine
• Medicines that affect potassium e.g. potassium supplements or certain diuretics (“water pills”) such as amiloride, triamterene, spironolactone or medicines containing potassium such as heparin
• Pain-relieving medicines such as indometacin and medicines known as “cox-2-inhibitors” because they may reduce the blood lowering effect of losartan. If you already have kidney problems then using these medicines together with losartan may worsen your kidney function.
• Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate
Taking Losartan with food and drink
Losartan may be taken with or without food.
Pregnancy and breast feeding Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advice you to stop taking Losartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan. Losartan is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Use in children and adolescents
Losartan may be prescribed for children and adolescents. For more information, talk to your doctor.
Driving and using machines
Losartan may cause side effects such as dizziness or drowsiness in some people and so may affect the ability to drive or use machines. If you experience side effects, you should consult your doctor before attempting such activities.
Important information about some of the ingredients of Losartan Tablets
Losartan contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE LOSARTAN
Always take Losartan Tablets exactly as your doctor has instructed you. Your doctor will decide on the appropriate dose of Losartan, depending on your condition and whether you are taking other medicines.It is important to continue taking Losartan for as long as your doctor prescribes it in order to maintain control of your blood pressure
Dosage in special patient groups
The doctor may advise a low dose of losartan especially when starting treatment in people with liver problems or people over the age of 75 years. The use of losartan is not recommended in patients with severe liver problems
Tablets should be swallowed with a glass of water. You should try to take your daily dose at about the same time each day. It is important that you continue to take Losartan until your doctor tells you otherwise.
If you take more Losartan than you should
If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately. Symptoms of overdose are low blood pressure and either a fast or slow pulse rate.
If you forget to take Losartan
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of Losartan tablets then ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Losartan can cause side effects, although not everybody gets them.
The following side effects are important and will require immediate action if you experience them.
You should stop taking Lorsatan and see your doctor immediately if the following symptoms occur:
Rare side effects affecting fewer than 1 in 1,000 patients:
• swelling of the face, tongue and windpipe which can cause great difficulty in breathing
• a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure
• stroke
Uncommon, affecting fewer than 1 in 100 people:
• Angina (heart pain)
The following side effects have also been reported:
Common, affecting up to 1 in 10 people:
• Dizziness, sensation of spinning
• Weakness, lassitude
• low blood pressure
• Low blood sugar
• Changes in blood test results that show how the liver and kidneys are working
Uncommon, affecting fewer than 1 in 100 people:
• sleepiness or other sleep disturbance
• skin rash, itch, hives
• headache
• palpitations
• fainting on standing (caused by low blood pressure)
• Breathlessness or difficulty breathing
• diarrhoea, nausea, vomiting, constipation
• fluid retention (causing, for example, swollen ankles)
Rare, affecting fewer than 1 in 1000 people:
• tingling sensation in the skin
• fainting
• allergic reactions
• inflammation of the small blood vessels
• liver problems
Not known (cannot be estimated from the available data):
• anaemia causing shortness of breath or looking pale
• bleeding or bruising more easily than normal
• back pain
• urinary infection
• flu-like symptoms
• migraine
• kidney problems (more common in those known to be at risk of kidney problems)
• muscle pains, j oint pains
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE LOSARTAN TABLETS
- Keep your tablets out of the reach and sight of children.
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protect
- Do not use Losartan Tablets after the expiry date which is stated on the carton after The expiry date refers to the last day of that month.
- Do not store your tablets above 25°C. Keep them in the original package in order to from light.
- Do not open the blister pack until you are ready to take the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Losartan Tablets contain
- The active substance is Losartan potassium
- The other ingredients are microcrystalline cellulose (E460), dibasic calcium phosphate, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate
The film-coat contains hypromellose (E464), lactose monohydrate, titanium dioxide (E171), polyethylene glycol 4000 and sodium citrate dihydrate.
Each Losartan potassium 25 mg tablet contains 25 mg of losartan (as potassium salt)
Each Losartan potassium 50 mg tablet contains 50 mg of losartan (as potassium salt)
Each Losartan potassium 100 mg tablet contains 100 mg of losartan (as potassium salt)
What Losartan looks like and contents of the pack
Losartan potassium 25 mg tablets are white, round shaped film-coated tablets debossed with L25 on one side and plain on other side.
Losartan potassium 50 mg tablets are white, oval shaped film- coated tablets with central break line on one side and L50 on the other side.
Losartan potassium 100 mg tablets are white, oval shaped film- coated tablets debossed with L100 on one side and plain on other side.
Losartan tablets are supplied in the following pack sizes:
Losartan 25 mg tablets are presented in a blister pack of 7 or 28 tablets.
Losartan 50 mg tablets are presented in a blister pack of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 mg tablets.
Losartan 100 mg tablets are presented in a blister pack of 7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 or 280 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Cipla (EU) Ltd,
Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW.
Manufacturer:
Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom