Amiloride/hydrochlorothiazide Aurovitas 5 mg/50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amiloride/Hydrochlorothiazide Aurovitas 5 mg/50 mg tablets EFG

amiloride hydrochloride/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Amiloride/Hydrochlorothiazide Aurovitas is and what it is used for
2. What you need to know before taking Amiloride/Hydrochlorothiazide Aurovitas
3. How to take Amiloride/Hydrochlorothiazide Aurovitas
4. Possible side effects
5. Storage of Amiloride/Hydrochlorothiazide Aurovitas
6. Contents of the pack and other information

1. What Amilorida/Hidroclorotiazida Aurovitas is and what it is used for

The active substance amiloride hydrochloride belongs to a group of medicines called antikaliuretic (potassium-sparing) agents; it is also a weak diuretic.

The active substance hydrochlorothiazide belongs to a group of medicines called thiazide diuretics.

Amilorida/Hidroclorotiazida Aurovitas is used in adult patients for the treatment of:

• High blood pressure
• Fluid retention in the body due to heart disease (cardiac edema)
• Fluid accumulation in the abdomen caused by a liver disease known as "ascites-producing liver cirrhosis".

2. What you need to know before taking Amiloride/Hydrochlorothiazide Aurovitas

Do not take Amiloride/Hydrochlorothiazide Aurovitas

• If you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• If you have diabetes (high blood sugar levels).
• If your doctor has told you that you have high levels of urea, creatinine, potassium, or calcium in your blood.
• If you are allergic to a type of antibiotic called sulfonamides, such as sulfamethoxazole.
• If you are allergic to acetazolamide, a diuretic used to eliminate fluid from the body and to treat high eye pressure (glaucoma), heart problems, and sometimes seizures or epilepsy.
• If you are allergic to any other diuretic tablet containing "thiazide".
• If you are taking potassium-sparing diuretics such as eplerenone, spironolactone, or triamterene.
• If you are taking potassium supplements or any medicine containing potassium, or consuming potassium-rich foods.
• If you have low sodium levels in your blood (hyponatremia).
• If you have kidney or liver disease.
• If you have Addison's disease.
• If you have difficulty urinating.

Do not take amiloride/hydrochlorothiazide if you are in any of the situations listed above. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amiloride/Hydrochlorothiazide Aurovitas if:

• Your doctor has told you that you have high levels of uric acid, cholesterol, or triglycerides (a type of fat) in your blood.
• You are taking digitalis drugs such as digoxin, used for heart failure and abnormal heartbeats.
• You are receiving intravenous fluids through a tube inserted into one of your veins.
• You have recently experienced severe vomiting or diarrhea.
• You have systemic lupus erythematosus (an autoimmune disease).
• You are elderly.
• You have gout.
• You have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Amiloride/Hydrochlorothiazide.
• If you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours or weeks after taking amiloride/hydrochlorothiazide. This can lead to permanent vision loss if not treated. If you have previously had an allergic reaction to penicillin or a sulfonamide, you may be at higher risk.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking amiloride/hydrochlorothiazide, seek medical attention immediately.

See also the section “Other medicines and Amiloride/Hydrochlorothiazide Aurovitas”.

Children and adolescents

Do not give this medicine to children under 18 years of age, as limited data are available.

Other medicines and Amiloride/Hydrochlorothiazide Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This includes herbal medicines. This is because this medicine may affect how other medicines work. Also, some medicines may affect how amiloride/hydrochlorothiazide works.

It is important that you inform your doctor or pharmacist if you are taking:

• Angiotensin-converting enzyme (ACE) inhibitors such as enalapril, used to treat high blood pressure or heart problems.
• Angiotensin II receptor antagonists, such as losartan, used to treat high blood pressure or diabetes with kidney damage.
• Other medicines for high blood pressure.
• Medicines for diabetes such as insulin or chlorpropamide.
• Lithium: used for depression.
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin or ibuprofen, used to reduce high temperature (fever), pain, or for arthritis.
• Barbiturates: used to help you sleep or reduce anxiety.
• Analgesics such as codeine, dihydrocodeine, dextropropoxyphene, diamorphine, morphine, pentazocine, and pethidine.
• Cholestyramine and colestipol: used to treat high cholesterol (hyperlipidemia).
• Steroids: used to treat many different conditions, such as rheumatism, arthritis, allergic conditions, skin problems, asthma, or a type of blood disorder.
• ACTH to test whether your adrenal glands are functioning properly.
• Injectable medicines for allergic reactions such as adrenaline (also known as epinephrine).
• Tacrolimus: used after liver or kidney transplant to prevent rejection.
• Cyclosporine: used for rheumatoid arthritis or to prevent rejection after transplant.
• Non-depolarizing muscle relaxants such as tubocurarine.
• Trilostane: used to treat breast cancer or overactive adrenal glands (as in Conn's syndrome, Cushing's syndrome).
• Allopurinol (to treat gout): co-administration with thiazides may increase the incidence of allergic reactions to allopurinol.
• Cytostatic agents (to treat cancer), e.g. cyclophosphamide, fluorouracil, methotrexate.
• Methyldopa (to treat hypertension).
• Amantadine (to treat Parkinson's disease).
• Carbamazepine (to treat epilepsy).

Additionally, if you are undergoing surgery, make sure the doctor treating you knows that you are taking amiloride/hydrochlorothiazide.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Tests while taking Amiloride/Hydrochlorothiazide Aurovitas

While taking this medicine, it may affect certain blood or urine tests. Please remember to inform your doctor that you are taking amiloride/hydrochlorothiazide if he or she orders any tests.

If you have diabetes or your doctor suspects you may have diabetes, you may need testing before starting treatment with amiloride/hydrochlorothiazide.

Use of amiloride/hydrochlorothiazide should be discontinued a few days before parathyroid function testing or glucose tolerance testing, as it may interfere with the results of these tests.

Taking Amiloride/Hydrochlorothiazide Aurovitas with food, drinks, and alcohol

Your doctor may have advised you to make slight changes to your diet and to avoid certain foods high in potassium. These include milk, bananas, raisins, and prunes. Your doctor will tell you which foods to avoid. If you are unsure which foods to avoid, consult your doctor before taking amiloride/hydrochlorothiazide tablets.

Your doctor may have advised you to minimize alcohol consumption while taking this medicine. Alcohol may enhance the effects of amiloride/hydrochlorothiazide, causing you to feel dizzy or lightheaded when standing up quickly.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant or think you might be. Your doctor will usually recommend an alternative medicine, as amiloride/hydrochlorothiazide is not recommended during pregnancy.

This is because amiloride/hydrochlorothiazide crosses the placenta and its use after the third month of pregnancy may cause potentially harmful fetal and neonatal effects.

Breastfeeding

The use of amiloride/hydrochlorothiazide is not recommended during breastfeeding. If you are breastfeeding or planning to breastfeed, consult your doctor.

Driving and using machines

Due to the possibility of dizziness, especially at the start of treatment or when the dose is increased, you should assess whether your ability to drive or operate machinery could be affected.

Use in athletes

This medicine contains amiloride and hydrochlorothiazide, which may result in a positive doping test.

Amiloride/Hydrochlorothiazide Aurovitas contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take Amiloride/Hydrochlorothiazide Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You must take this medicine orally. The amount you take each day will depend on your condition.

The recommended dose is:

High blood pressure

• The usual dose is one 5 mg/50 mg tablet daily.
• Some patients may require only 2.5 mg/25 mg once daily.
• Your doctor may divide the dose or administer it as a single dose.

Edema of cardiac origin

• The usual starting dose is one 5 mg/50 mg tablet daily.
• Your doctor may adjust your dose.
• You must not take more than two tablets per day.

Fluid retention due to cirrhosis

• The usual starting dose is one 5 mg/50 mg tablet daily.
• Your doctor may adjust your dose.
• You must not take more than two tablets per day.

For 5 mg/50 mg: tablets may be divided to facilitate dose adjustment, if instructed by your doctor.

If you take more Amiloride/Hydrochlorothiazide Aurovitas than you should

If you have taken too much Amiloride/Hydrochlorothiazide Aurovitas by mistake, contact your doctor or seek medical help immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amiloride/Hydrochlorothiazide Aurovitas

• If you forget to take your dose, skip the missed dose.
• Take your next dose as usual.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Amiloride/Hydrochlorothiazide Aurovitas

Do not stop taking this medicine without speaking to your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects may occur with this medicine:

Stop taking this medicine and consult a doctor immediately if you notice any of the following serious side effects, which may occur. You may need urgent medical treatment:

• allergic reactions: signs may include inflamed blood vessels, difficulty breathing or swallowing, collapse, redness, blisters, peeling of the skin, muscle pain, chills, general feeling of discomfort, mouth, eye or genital ulcers,
• irregular heartbeats that may cause fainting and dizziness, palpitations,
• rapid heartbeats, chest pain (angina),
• gastrointestinal bleeding: signs may include blood in the stool or darker-colored stools,
• liver problems such as jaundice – signs may include yellowing of the skin and/or whites of the eyes.

Other adverse effects include:

Frequent (may affect up to 1 in 10 people):

• headache,
• weakness,
• dizziness,
• fatigue,
• feeling sick (nausea),
• loss of appetite (anorexia),
• diarrhoea,
• abdominal pain (stomach pain and stomach cramps),
• rash,
• pruritus,
• increased heart rate (arrhythmias),
• difficulty breathing (dyspnoea),
• increased blood sugar levels,
• increased levels of uric acid in the blood (may cause symptoms of gout),
• increased potassium levels in the blood,
• pain in the limbs.

Uncommon (may affect up to 1 in 100 people):

• bad taste in the mouth,
• dry mouth,
• vomiting,
• abdominal fullness,
• constipation,
• flatulence,
• digestive disorders,
• nasal congestion and hiccups,
• dehydration due to excessive fluid elimination, thirst, and low sodium levels in the blood,
• muscle cramps, joint pain (arthralgia), back pain,
• impotence,
• feeling dazed (stupor),
• feeling dizzy when standing up quickly,
• sleep disturbances, nervousness, depression, and confusion,
• increased need to urinate at night, difficulty urinating, and urinary incontinence,
• visual disturbances,
• increased levels of cholesterol and triglycerides in the blood,
• sensation of dizziness, spinning sensation (vertigo), tingling,
• increased sweating,
• rapid heartbeats, chest pain (angina).

Rare (may affect up to 1 in 1,000 people):

• syncope and allergic hypersensitivity with rapidly developing general symptoms (anaphylaxis),
• gastrointestinal haemorrhages, ulcers,
• inflammation of blood vessels (vasculitis),
• decreased kidney function,
• cholestasis, jaundice,
• cough,
• xanthopsia,
• palpitations.

Very rare (may affect up to 1 in 10,000 people):

• changes in blood count and anaemia,
• decreased or complete lack of white blood cells and reduced platelets in the blood,
• brain disease (encephalopathy),
• sensation of trembling (tremors),
• increased pressure in the eyes,
• ringing in the ears (tinnitus),
• lung inflammation,
• increased body temperature (fever),
• stomatitis,
• swelling of the glands that produce saliva (sialadenitis),
• pancreatitis,
• erythema and red skin spots, photosensitivity,
• hair loss (alopecia),
• kidney inflammation (nephritis),
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency not known: (cannot be estimated from available data)

• feeling sleepy or, sometimes, feeling unable to sleep,
• feeling restless,
• reduced sexual desire,
• chest pain (angina pectoris),
• excessive and frequent urination,
• spreading of severe skin rashes, blisters or mucosal lesions,
• skin and lip cancer (non-melanoma skin cancer),
• sudden decrease in distance vision (acute myopia), decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amiloride/Hydrochlorothiazide Aurovitas

Keep this medicine out of the sight and reach of children.

Store below 30ºC.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amiloride/Hydrochlorothiazide Aurovitas

• The active substances are amiloride hydrochloride and hydrochlorothiazide. Each tablet contains 5.68 mg of amiloride hydrochloride dihydrate, equivalent to 5 mg of amiloride hydrochloride and 50 mg of hydrochlorothiazide.
• The other excipients are: monohydrate lactose, pregelatinized starch (corn starch), corn starch, calcium hydrogen phosphate dihydrate, povidone (K-30), talc, magnesium stearate, yellow iron oxide (E172) and red iron oxide (E172).

Appearance of the product and contents of the pack

Tablet.

Light orange-coloured, diamond-shaped, biconvex, uncoated tablets, marked with "AH" and "2" separated by a score line on one side and a score line on the other side. The tablet size is approximately 10.8 mm x 8 mm.

The tablet can be divided into equal doses.

Amiloride/Hydrochlorothiazide Aurovitas tablets are available in blister packs.

Pack sizes:

Blister packs: 10, 20, 30, 50, 60 and 90 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

OR

Generis Farmacêutica S.A.,

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora,

Portugal

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Amiloride/Hydrochlorothiazide Aurovitas 5 mg/50 mg tablets EFG

Italy: Amiloride e Idroclorotiazide Aurobindo

Netherlands: Amiloride HCl/Hydrochloorthiazide Auro 5 mg/50 mg, tabletten

Portugal: Amilorida + Hidroclorotiazida Generis

Date of the most recent review of this leaflet: May 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)