AMERIDE 5 mg/50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ameride 5 mg/50 mg Tablets

amiloride hydrochloride/hydrochlorothiazide

Read all of this leaflet carefully before you start taking 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Ameride and what is it used for

The amiloride component of Ameride belongs to a group of medicines called potassium-sparing diuretics: amiloride is also a weak diuretic. The hydrochlorothiazide component of Ameride belongs to a group of medicines called diuretics (thiazides).

Ameride works by making the kidneys remove more water and salts and retain more potassium.

This helps to reduce high blood pressure and some types of swelling, while also helping to maintain normal potassium levels in the blood.

Ameride is indicated for the treatment of high blood pressure (hypertension), especially in patients with low potassium levels; cardiac edema (swelling of the ankles, feet, or legs due to fluid retention); or ascites (fluid accumulation in the abdomen) due to cirrhosis (liver disease).

2. What you need to know before you take Ameride

Do not take Ameride

• if you are allergic to amiloride hydrochloride, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to any sulfonamide-derived medication (consult your doctor if you are not sure what medications are sulfonamide-derived).
• if you have high potassium levels in your blood.
• if you are taking other medications or supplements that increase potassium levels in your blood.
• if you have kidney disease.

Consult your doctor if you are not sure if you should start taking this medicine.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Ameride:

• if you have or have had any medical problems or allergies, inform your doctor.
• inform your doctor if you have high potassium levels in your blood. Inform your doctor if you have any heart or lung problems, liver or kidney problems, gout, or lupus (an autoimmune disease), or if you are being treated with other diuretics. In such cases, your doctor may adjust the dose of your medications.
• if you have diabetes (high blood sugar levels), consult your doctor, as treatment with thiazides may require an adjustment of the dose of antidiabetics, including insulin.
• before surgical interventions or anesthesia (even at the dentist), inform your doctor or dentist that you are taking Ameride, as a sudden drop in blood pressure associated with anesthesia may occur.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment, consult your doctor. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Ameride.
• if you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within a few hours to a week after taking Ameride. If left untreated, this can lead to permanent vision loss. If you have previously had an allergic reaction to penicillin or a sulfonamide, you may be at higher risk of developing this.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Ameride, seek medical attention immediately.

Children and adolescents

Safety and efficacy have not been established in children, therefore, administration is not recommended in minors.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Other medicines and Ameride

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In general, Ameride can be taken with other medicines. However, it is essential to inform your doctor about any other medication you are taking, including those without a prescription, as some medications can compromise the action of others.

It is especially important that your doctor knows if you are taking any ACE inhibitors (used to treat high blood pressure), other potassium-sparing medications, or potassium supplements. Also, inform your doctor if you are taking other antihypertensive medications, other diuretics, cholesterol-lowering resins, antidiabetics, including insulin, muscle relaxants, pressor amines such as adrenaline (medications used in case of cardiac arrest or severe allergic reactions), steroids, certain painkillers and anti-inflammatory medications, medications that decrease the action of the body's defenses (cyclosporine, tacrolimus), or lithium (a medication used in some types of depression). The use of sedatives, narcotics, tranquilizers, alcohol, and painkillers may increase the antihypertensive effect of Ameride, so you should inform your doctor if you take any of these.

Taking Ameride with food and drinks

Inform your doctor if you take potassium supplements or follow a potassium-rich diet.

Pregnancy and breastfeeding

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

The use of Ameride is not recommended during pregnancy.

The hydrochlorothiazide component of Ameride passes into breast milk. If treatment with this medicine is essential, breastfeeding should be discontinued.

Driving and using machines

No data are available on the effects on the ability to drive and use machines.

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Ameride contains orange yellow and lactose

This medicine may cause allergic reactions because it contains orange yellow S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Ameride

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide the suitable dose, according to your condition and whether or not you are taking other medications.

Most people take the tablets with a little water.

Take Ameride daily. Do not take more tablets than the prescribed dose.

Follow these instructions unless your doctor has given you different instructions.

Remember to take your medicine.

• Cardiac edema

The usual initial dose is one Ameride tablet per day.

• Hypertension

The usual initial dose is one Ameride tablet taken once a day or divided into two doses.

• Cirrhosis with ascites

The usual dose is one Ameride tablet taken once a day.

This dose may be increased by your doctor if necessary, without exceeding two tablets per day. In some patients, maintenance treatment may be controlled with intermittent dosing if your doctor indicates so.

The tablets can be divided to facilitate dose adjustment if your doctor indicates so.

If you think the action of Ameride is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the duration of your treatment with Ameride. Do not stop treatment before, as only your doctor knows what is best for you.

Use in children

Safety and efficacy have not been established in children, therefore, administration is not recommended in minors.

If you take more Ameride than you should

In case of overdose, call your doctor immediately. The most likely symptoms will be dizziness or lightheadedness, due to low blood pressure and/or excessive thirst, confusion, reduced urine volume, or rapid heartbeats.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562 04 20.

If you forget to take Ameride

Do not take a double dose to make up for forgotten doses.

If you stop taking Ameride

Do not stop taking this medicine without consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immune system disorders:anaphylactic reaction.

Blood and lymphatic system disorders:changes in blood cell count, red spots on the skin.

Metabolism and nutrition disorders:most frequently: anorexia (loss of appetite); may cause changes in your blood test results related to sodium, potassium, glucose, and uric acid levels. It may also increase glucose levels in urine. Gout, dehydration.

Psychiatric disorders:insomnia, nervousness, mental confusion, depression, drowsiness, agitation, decreased libido.

Nervous system disorders:headache*, dizziness*; fainting, vertigo, tingling sensation, stupor, tremors, brain disease, bad taste in the mouth.

Eye disorders:decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma], vision changes, ocular hypertension (increased pressure inside the eye).

Ear and labyrinth disorders:ringing in the ears.

Cardiac disorders:arrhythmia (change in heart rate), tachycardia (increased heart rate), chest pain, and palpitations (strong and rapid heartbeats).

Vascular disorders:orthostatic hypotension (dizziness or lightheadedness due to low blood pressure when standing up suddenly) and other heart anomalies.

Respiratory, thoracic, and mediastinal disorders:cough, respiratory disorders, chest pain, difficulty breathing, nasal congestion.

Gastrointestinal disorders:most frequently: nausea; vomiting, diarrhea, constipation, abdominal pain, gastrointestinal bleeding, changes in appetite, abdominal heaviness, flatulence (gas), thirst, hiccups, bad taste in the mouth, dry mouth, cramps, difficult digestion, pancreatitis, stomach pain and/or ulcer.

Hepatobiliary disorders:may cause changes in your blood test results related to liver enzymes and bilirubin.

Skin and subcutaneous tissue disorders:most frequently: skin rash; itching, redness, sweating, hair loss, sensitivity to light, inflammation of the salivary glands, blistering, toxic epidermal necrolysis (a severe skin reaction characterized by blistering).

Frequency not known: Skin and lip cancer (non-melanoma skin cancer).

Musculoskeletal and connective tissue disorders:limb pain, muscle cramps, joint pain, back pain, neck and shoulder pain.

Renal and urinary disorders:changes in urination, renal dysfunction including kidney failure, kidney inflammation.

Reproductive system and breast disorders:impotence.

General disorders and administration site conditions:fatigue, malaise, weakness, allergic reaction, fever.

Very rare: Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

When side effects occur, your doctor may reduce the dose of Ameride or interrupt treatment.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ameride

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

Do not store above 25°C.

Store in the outer packaging to protect from light and moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Dispose of the packaging and any unused medicine in the SIGRE Point of the pharmacy. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ameride

• The active ingredients are amiloride hydrochloride and hydrochlorothiazide. Each scored tablet contains 5 mg of amiloride hydrochloride and 50 mg of hydrochlorothiazide.

• The other ingredients are: lactose monohydrate, calcium hydrogen phosphate dihydrate, corn starch, pregelatinized starch, guar gum, magnesium stearate, aluminum lake of orange yellow S (E-110).

Appearance of the product and packaging

Ameride is presented in the form of scored tablets, in blisters, in packs of 20 and 60 tablets. The tablets are peach-colored, engraved with "AMERIDE" on one side and scored on the other.

Marketing authorization holder and manufacturer

Marketing authorization holder

PAN QUÍMICA-FARMACÉUTICA, S.A.

Rufino González, 50

28037 Madrid

Spain

Manufacturer

ROVI Pharma Industrial Services, S.A.

Vía Complutense, 140

Alcalá de Henares 28805 – Madrid

(Spain)

Local representative

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Date of last revision of this leaflet: February 2022

Other sources of information

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