Enalapril Maleate/Hydrochlorothiazide 20mg/12.5mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Enalapril Maleate and ratiopharm
Hydrochlorothiazide 20 mg/12.5 mg tablets
Enalapril maleate and hydrochlorothiazide
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Enalapril Maleate and Hydrochlorothiazide tablets is and what it is used for
2. What you need to know before you take Enalapril Maleate and Hydrochlorothiazide tablets
3. How to take Enalapril Maleate and Hydrochlorothiazide tablets
4. Possible side effects
5. How to store Enalapril Maleate and Hydrochlorothiazide tablets
6. Contents of the pack and other information
1. WHAT ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS IS AND WHAT IT IS USED FOR
Enalapril Maleate and Hydrochlorothiazide tablets belongs to the group of combination medicines used to treat high blood pressure (hypertension). It contains two active ingredients, enalapril (an ACE inhibitor) and hydrochlorothiazide (a diuretic). Enalapril prevents the formation of substances in the body that cause a rise in blood pressure, and hydrochlorothiazide increases the removal of water and salts from the body, which also lowers the blood pressure.
Enalapril Maleate and Hydrochlorothiazide tablets is used in patients whose blood pressure is successfully controlled by taking the same amounts of each ingredient as a separate medicine.
2. BEFORE YOU TAKE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS
Do not take Enalapril Maleate and Hydrochlorothiazide tablets
• if you are allergic (hypersensitive) to enalapril maleate, other ACE-inhibitors, thiazides (medicines for increasing urine output), sulfonamide derivatives (certain antibiotics and medicines for diabetes) or any of the other ingredients of Enalapril Maleate and Hydrochlorothiazide tablets (see section 6)
• if you or anyone among your blood relatives have previously suffered from swelling of the extremities, face, lips, throat, mouth or tongue (angioedema) under any circumstances
• if you are more than 3 months pregnant (It is also better to avoid Enalapril Maleate and Hydrochlorothiazide tablets in early pregnancy -see pregnancy section)
• if you have severe kidney or liver problems
• if you are not passing urine
• if you have diabetes or kidney problems and are taking a medicine called aliskiren to reduce blood pressure.
Warnings and precautions
The doctor who has prescribed this medicine must be aware of the following:
• if you are using diuretics ("water tablets")
• if you are on a salt restricted diet or if you are currently suffering or suffer during treatment from severe diarrhoea or vomiting
• if you have abnormal levels of water and minerals in your body (fluid/electrolyte imbalance)
• if you have heart failure
• if you have narrowing of the arteries (atherosclerosis) or a cerebrovascular disease (such as a stroke)
• if you have heart muscle disease (hypertrophic cardiomyopathy), a narrowing of the main artery carrying blood away from the heart, the aorta (aortic stenosis), or other forms of a heart problem called outflow obstruction
• if you undergo LDL apheresis (removal of cholesterol from the blood by a machine)
• if you have kidney problems or narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney, or you are receiving dialysis
• if you have recently had a kidney transplant
• if you have diabetes
• if you have a collagen vascular disease such as systemic lupus erythematosus (SLE) or scleroderma or if you are treated with immunosuppressants, allopurinol or procainamide, or a combination of these
• if your liver is not working properly
• if you are receiving desensitization therapy against insect toxins
• if you have allergy problems or asthma
• if you need to undergo surgery during the treatment, because some anaesthetic agents used during surgery may cause excessive drop in blood pressure in combination with Enalapril Maleate and Hydrochlorothiazide tablets
• if you have high levels of potassium in your blood.
You must tell your doctor if you think that you are (or might become) pregnant. Enalapril Maleate and Hydrochlorothiazide tablets 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).
Sudden swelling of the tongue, lips and face, neck, possibly also hands and feet, or wheezing or hoarseness may occur at any time during treatment. This condition is called angioedema. If this happens, stop taking Enalapril Maleate and Hydrochlorothiazide tablets and tell your doctor. ACE inhibitors cause a higher rate of angioedema in black patients than in non-black patients.
If dry cough occurs during treatment, consult your doctor, who will decide whether or not treatment should be continued.
Children and adolescents
Do not give Enalapril Maleate and Hydrochlorothiazide tablets to children under 18 years. There is limited information on the safety and effectiveness of Enalapril Maleate and Hydrochlorothiazide tablets in children.
Kidney
If your kidneys are not working well, it is important that you are not using potassium supplements or potassium sparing diuretics during treatment with enalapril/hydrochlorothiazide because they may increase potassium levels in your body excessively.
Hydrochlorothiazide contained in this medicinal product can produce a positive analytic result in an anti-doping test.
Other medicines and Enalapril Maleate and Hydrochlorothiazide tablets
Taking Enalapril Maleate and Hydrochlorothiazide tablets with other medicines may affect the efficacy and safety of this medicine. On the other hand, Enalapril Maleate and Hydrochlorothiazide tablets may affect the efficacy and safety of 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, herbal products or natural remedies. Remember to tell your doctor about Enalapril Maleate and Hydrochlorothiazide tablets if he/she prescribes you another medicine during the therapy or soon after it.
It is especially important to tell your doctor if you are using any of the following:
• potassium-sparing diuretics ("water tablets"), such as spironolactone, triamterene or amiloride potassium or calcium supplements, or dietary or salt supplements containing potassium or calcium. The combination could lead to dangerously high potassium or calcium levels in your blood
• other antihypertensive agents of high-dosed diuretics ("water tablets"). This combination could cause your blood pressure to fall dangerously low
• allopurinol (gout medicine), procainamide (medicine to treat problems with heart rhythm), cytostatic agents (cancer medicines) or medicines affecting the body's immune system (such as cyclosporine)
• lithium (medicine used to treat mental health problems). The combination could cause your body to accumulate too much lithium and therefore increase the risk of side effects
• antipsychotic medicines, certain medicines used to treat depression (tricyclic antidepressants) or medicines stimulating the central nervous system
• certain anaesthetic medicinal products, barbiturates or strong pain killers. The combination may cause you to feel dizzy when you stand up
• trimethoprim (an antibiotic for urinary tract infections)
• anti-inflammatory medicines (NSAIDs)
• carbenoxolone (used to sooth ulcers), corticosteroids, corticotroptin (ACTH, used to treat epilepsy) or stimulant laxatives. The combination could lead to abnormal levels of water and minerals in your body, particularly lack of potassium
• cardiac glycosides (like digitoxin) or tubocarin (muscle relaxant). The effect of these medicinal products may be enhanced
• insulin or oral diabetes medicines
• cholestyramine or colestipol (cholesterol binding medicines).
Enalapril Maleate and Hydrochlorothiazide tablets with food and drink
Enalapril Maleate and Hydrochlorothiazide tablets may be taken with fluid on an empty stomach or with food.
You should be aware that drinking alcohol can enhance the effect of this medicine.
Pregnancy and breast-feeding Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Enalapril Maleate and Hydrochlorothiazide tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Enalapril Maleate and Hydrochlorothiazide tablets. Enalapril Maleate and Hydrochlorothiazide tablets 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. Enalapril Maleate and Hydrochlorothiazide tablets is not recommended for mothers who are breast-feeding.
Driving and using machines
Enalapril Maleate and Hydrochlorothiazide tablets may make you feel tired or dizzy, which may affect your ability to drive or use machinery requiring special care.
Enalapril Maleate and Hydrochlorothiazide tablets contain lactose
This product 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 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS
Always take Enalapril Maleate and Hydrochlorothiazide tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is 1 tablet once daily.
Use in Children and adolescents
Children should not take this medicine, as it has not been tested for children.
Older People
Your dose will be decided by your doctor. It will depend on how well your kidneys are working.
Dosage in patients with kidney problems
The dosage depends on how well your kidneys are working. Follow the instructions of your doctor.
Prior diuretic therapy
Treatment with diuretics other than hydrochlorothiazide should be discontinued 2 to 3 days before the start of the treatment with Enalapril Maleate and Hydrochlorothiazide tablets.
Follow the instructions of your doctor.
Do not change the dosage or stop taking the medicine without discussing it first with your doctor.
If you take more Enalapril Maleate and Hydrochlorothiazide tablets than you should
Always contact your doctor or nearest hospital immediately if you have taken more than you should (overdose). An overdose is likely to cause low blood pressure, an excessively fast or slow heart beat, palpitations (a feeling of unduly rapid or irregular heart beat), shock, rapid breathing, cough, feeling and being sick, cramps, dizziness, feeling sleepy and confused or anxious, excessive urination or not being able to urinate.
If you forget to take Enalapril Maleate and Hydrochlorothiazide tablets
Take the next dose when it is the normal time to take it. Do not take a double dose to make up for a forgotten dose.
If you stop taking Enalapril Maleate and Hydrochlorothiazide tablets
The treatment of hypertension is a long term treatment and interruption of treatment must be discussed with the doctor. Interruption or stopping your treatment could cause your blood pressure to increase.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Enalapril Maleate and Hydrochlorothiazide tablets can cause side effects, although not everybody gets them.
Stop taking this medicine and see a doctor or go to a hospital straightaway if:
• you get swelling of the hands, feet, ankle, face, lips or throat which may cause difficulty in swallowing or breathing, itching of the skin and nettle rash. This is a serious and common side effect called angioedema (affects 1 to 10 patients in 100)
• you get red, swollen or scalded skin with blisters on the lips, eyes, mouth, nose and/or genitals. You may also have a high temperature, swollen glands or joint pain. This could be a rare condition called Stevens-Johnson syndrome (affects less than 1 patient in 1,000).
This may mean you are having an allergic reaction to Enalapril Maleate and Hydrochlorothiazide tablets. Talk to your doctor straight away if you notice any of the following serious side-effects.
These are uncommon or rare (affect less than 1 patient in 100):
• You may get a bloating feeling and cramping pain in the stomach (abdomen), be sick (vomiting), have indigestion, heartburn, upset stomach, constipation, loss of appetite, dry mouth. This could be caused by an obstruction or blockage of the bowel (ileus)
• Severe stomach pains which may reach through to your back. This could be a sign of pancreatitis
• Blood disorders including bone marrow problems and anaemia. Symptoms include bruising more easily, bleeding longer after injury, bleeding from the gums or elsewhere, purple spots or blotching on the skin (caused by damage to small blood vessels), a greater chance of infection
• Lung problems including inflammation of the lungs. You may feel unwell or less hungry, or get high temperature (fever) lasting 2 to 3 days, difficulty breathing, shortness of breath, cough
• High temperature, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of the skin or eyes (jaundice). These are symptoms of Hepatitis (inflammation of the liver) that may lead to liver failure
• A condition which may include some or all of the following: high temperature, inflamed blood vessels, painful inflamed muscles and joints, blood problems detected by a blood test, rash, being very sensitive to sunlight, other effects of the skin.
Other possible side effects:
Very common (in more than 1 of 10 patients)
• Dizziness
• Blurred vision
• Feeling sick
• Cough
• Weakness.
Common (in 1 to 10 of 100 patients):
• Headache
• Tiredness
• Chest pain
• Fainting
• Altered and/or irregular heartbeat
• Low blood pressure, including postural hypotension with associated symptoms (dizziness, weakness, blurred vision)
• Diarrhoea
• Distortion or decrease of the sense of taste
• Abdominal pain
• Exanthema (rash)
• Muscle spasms
• Changes in blood levels of potassium
• Increase in blood levels of creatinine and fat
• Excessive blood urine acid levels
• Depression
• Difficulty in breathing.
Uncommon (in 1 to 10 of 1,000 patients):
• Vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, peptic ulcer, flatulence
• Kidney problems, protein in the urine
• Impotence
• Reduction in the number of red blood cells, which can make the skin pale and cause weakness or breathlessness (anaemia)
• Palpitations (a sensation of a fast or particularly strong or irregular heart beat)
• Heart attack or cerebrovascular accident ("mini-stroke") (mainly in patients suffering from low blood pressure)
• Confusion, drowsiness, sleeplessness, nervousness, sensations of tingling, pricking or numbness (paraesthesia)
• Vertigo (dizziness)
• Joint pain, feeling unwell, fever
• Red face, ringing in the ears (tinnitus)
• Itch, hives, hair loss
• Runny nose, sore throat and hoarseness, wheezing
• Excessive sweating
• Gout
• Low blood sodium and/or magnesium levels, decreased blood glucose levels
• Inflammation of the gallbladder, especially in patients with gallstones.
Rare (in 1 to 10 of 10,000 patients):
• Changes in blood count, disease of the lymph nodes, autoimmune disease, in which the body attacks itself
• Stomatitis, glossitis
• Allergic skin reactions (e.g. erythema multiforme, redness, scaling or blistering of the skin, epidermal necrolysis [serious condition with detachment of the top layer of the skin], purpura), skin conditions with red scaly patches over the nose and cheeks (lupus erythematosus)
• Inflammation of the lining of the nose causing the nose to run (rhinitis)
• Reduced urine production
• Inflammation in the kidneys (interstitial nephritis)
• Breast enlargement including in men
• Dream abnormality, disturbed sleep
• Impaired muscle movement (due to low blood potassium levels)
• Raynaud's phenomenon. (Symptoms include fingers that change colour when exposed to the cold or when pressure is put on them, pain in the fingers or toes when cold, tingling or pain on warming.)
• Increase in the amount of enzymes and waste products produced by the liver.
Very rare (in less than 1 of 10,000 patients)
• A condition called "intestinal angioedema". Symptoms are stomach pain with or without feeling sick or being sick
• Increase in blood calcium.
Not known (cannot be determined based on the available data)
• Inflammation of a salivary gland
• Increased blood sugar, glucose in the urine
• Restlessness
• Light-headedness
• Vision disturbances
• Inflammation of the blood vessels
• Anaphylactic reactions (allergic hypersensitivity which develops rapidly, with generalised symptoms)
• Syndrome of inappropriate antidiuretic hormone secretion (symptoms include headache, nausea, vomiting, agitation or confusion and may progress to convulsions and coma if left untreated).
Reporting of side effects
If any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS
Keep out of the reach and sight of children.
Do not use Enalapril Maleate and Hydrochlorothiazide tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Enalapril Maleate and Hydrochlorothiazide tablets contain
The active substances are enalapril maleate and hydrochlorothiazide. Each tablet contains 20 mg enalapril maleate and 12.5 mg hydrochlorothiazide. The other ingredients are lactose monohydrate, maize starch, sodium hydrogen carbonate, starch pregelatinised, talc and magnesium stearate.
What Enalapril Maleate and Hydrochlorothiazide tablets look like and contents of the pack
Round, white, flat tablet, scored on one side and with bevelled edge. Diameter 8mm.
The tablets can be divided into equal halves.
They are available in blister packs of 14, 20, 28, 28 x 1, 30, 30 x 1,56, 60, 98, 98 x 1, 100, 100 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany.
Manufacturer
Merckle GmbH, Graf-Arco-Str.3, D-89079 Ulm, Germany.
This leaflet was last revised in October 2013.
PL 15773/0059