Package Insert: Information for the User

Ameride 5 mg/50 mg Tablets

amiloride hydrochloride/hydrochlorothiazide

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to other peopleeven if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Ameride and what is it used for

2. What you need to know before starting to take Ameride

3. How to take Ameride

4. Possible adverse effects

5. Storage of Ameride

6. Contents of the package and additional information

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

Ameride acts by causing the kidneys to eliminate more water and salts and retain more potassium.

This helps to reduce hypertension and some forms of edema, while at the same time helping to maintain normal levels of potassium in the blood.

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

Do not take Ameride

• if you are allergic to hydrochlorothiazide, amiloride hydrochloride, or any of the other components of this medication (listed in section 6).
• if you are allergic to any sulfonamide-derived medications (consult your doctor if you are unsure which medications are derived from sulfonamides).
• if you naturally have high levels of potassium in your blood.
• if you are taking other medications or supplements that increase the amount of potassium in your blood.
• if you have kidney disease.

Consult your doctor if you are unsure whether you should start taking this medication.

Warnings and precautions

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

• if you have or have had any medical problems or any allergies, inform your doctor.
• inform your doctor if you have high levels of potassium in plasma. Inform your doctor if you have any heart or lung disease, liver or kidney problems, gout, or lupus erythematosus (autoimmune disease), or if you are being treated with other diuretics. In such cases, your doctor may modify the dosage of your medications.
• if you have diabetes (high blood sugar levels), consult your doctor, as treatment with thiazides may require adjustment of the dosage of antidiabetic medications, including insulin.
• before surgical interventions or anesthesia (including dental procedures) inform your doctor or dentist that you are taking Ameride, as a sudden drop in blood pressure may occur associated with anesthesia.
• if you have had skin cancer or if a skin lesion appears unexpectedly during treatment, consult your doctor. The treatment with hydrochlorothiazide, particularly 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 exposure and UV rays while taking Ameride.
• if you experience a decrease in vision or eye pain, it may be a symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which 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 had a previous 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

The safety and efficacy of Ameride have not been established in children, therefore it is not recommended for use in minors.

Consult your doctor, even if any of the previously mentioned circumstances have occurred at any time.

Other medications and Ameride

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Ameride can generally be taken with other medications. However, it is essential to inform your doctor of any other medications you are taking, including those without a prescription, as some medications may interact with each other.

It is especially important for your doctor to know if you are taking any angiotensin-converting enzyme (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, antidiabetic medications, including insulin, muscle relaxants, pressor amines such as adrenaline (medications used in case of cardiac arrest or severe allergic reactions), steroids, certain analgesics and anti-inflammatory medications, medications that reduce the action of the body's defenses (ciclosporin, tacrolimus), or lithium (medication used in certain types of depression). The use of sedatives, narcotics, tranquilizers, alcohol, and analgesics may increase the antihypertensive effect of Ameride, so you should inform your doctor if you are taking any of these.

Ameride with food and beverages

Inform your doctor if you are taking potassium supplements or consuming a diet rich in potassium.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The use of Ameride is not recommended during pregnancy.

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

Driving and operating machinery

No data are available on the effects on the ability to drive and operate machinery.

Use in athletes

Since this medication contains a component that may result in a positive analytical result for doping control, inform athletes.

Ameride contains yellow orange and lactose

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

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide on the suitable dose, according to the patient's condition and whether they are taking other medications or not.

Most people take the tablets with a little water.

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

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

Remember to take your medication.

• 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 schedules if your doctor indicates so.

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

If you estimate that 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 suspend treatment beforehand, as only your doctor knows what is best for you.

Use in children

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

If you take more Ameride than you should

In case of overdose, call your doctor immediately. The most likely symptoms will be a feeling of dizziness or drowsiness, due to the decrease in blood pressure and/or excessive thirst, confusion, reduced urine volume, or rapid heartbeats (strong and rapid heartbeats).

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

If you forgot to take Ameride

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ameride

Do not stop taking this medication without consulting your doctor.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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:more frequently: loss of appetite; may cause changes in blood tests related to sodium, potassium, glucose, and uric acid levels. It may also increase glucose levels in urine. Gout, dehydration.

Mental disorders:insomnia, nervousness, mental confusion, depression, feeling of drowsiness, agitation, reduced sex drive.

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

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

Ear and labyrinth disorders:ringing in the ears.

Cardiac disorders:arrhythmia (alteration of heart frequency), tachycardia (increased heart frequency), chest pain, and palpitations (strong and rapid heartbeats).

Vascular disorders:orthostatic hypotension (dizziness or drowsiness due to a sudden drop in blood pressure when standing up) and other heart anomalies.

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

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

Hepatobiliary disorders:may cause changes in blood tests related to liver enzymes and bilirubin.

Skin and subcutaneous tissue disorders:more frequently: skin rash; itching, redness, sweating, hair loss, light sensitivity, salivary gland inflammation, blister formation, toxic epidermal necrolysis (severe skin reaction characterized by blister formation).

Unknown frequency: 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:urination changes, renal dysfunction including kidney failure, kidney inflammation.

Reproductive and breast system disorders:impotence.

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

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

When side effects appear, your doctor may reduce the dose of Ameride or discontinue treatment.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25 °C.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty packaging and unused medications. Dispose of empty packaging and unused medications at the SIGRE drop-off point at the pharmacy. By doing so, you will help protect the environment.

Composition of Ameride

• The active principles are hydrochlorothiazide and hydrochlorothiazide. Each scored tablet contains 5 mg of hydrochlorothiazide and 50 mg of hydrochlorothiazide.

• The other components are: lactose monohydrate, calcium dihydrogen phosphate, cornstarch, pregelatinized starch, guar gum, magnesium stearate, and aluminium lake yellow-orange S (E-110).

Appearance of the product and contents of the packaging

Ameride is presented in the form of scored tablets, in blister packaging, in containers of 20 and 60 tablets. The tablets are orange in color, engraved with “AMERIDE” on one side and scored on the other.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

PAN QUÍMICA-FARMACÉUTICA, S.A.

Rufino González, 50

28037 Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet: February 2022

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/