Leaflet: information for the user

Acyline620 mg/380 mg/630 mgOral suspension

Algeldrate, magnesium hydroxide, aluminium hydroxide-magnesium carbonate, coprecipitated

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

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

1. What isACYLINEand what it is used for

2. What you need to know before starting to takeACYLINE

3. How to takeACYLINE

4. Possible side effects

5. Storage ofACYLINE

6. Contents of the pack and additional information

ACYLINE contains algeldrate, magnesium hydroxide and aluminium hydroxide-magnesium carbonate, coprecipitated. It belongs to the group of drugs known as antacids, which act by neutralizing excess stomach acid.

ACYLINE is indicated for the relief and symptomatic treatment of stomach acid and heartburn in adults and individuals over 12 years old.

Consult a doctor if symptoms worsen or do not improve after 14 days.

Do not take ACYLINE:

• If you are allergic to aluminium hydroxide, magnesium hydroxide, or the coprecipitated aluminium carbonate of magnesium, or to any of the other components of this medication (listed in section 6).
• If you have symptoms of appendicitis, intestinal obstruction, or inflammation, such as abdominal pain, cramps, bloating, painful sensation, nausea, or vomiting.
• If you have severe kidney failure.
• If you experience gastrointestinal or rectal bleeding without a diagnosis.
• If you have hypermagnesemia (high levels of magnesium in the blood).
• If you have alkalosis (an imbalance of the acid-base balance in the blood).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take ACYLINE.

Like other antacids, this medication may mask the symptoms of a more serious stomach disease, such as a peptic ulcer or a malignant process, so if symptoms persist or worsen after 14 days of treatment, consult your doctor.

If you are on a low-phosphorus diet, experience diarrhea, poor absorption, or have had a kidney transplant, there may be a decrease in phosphate levels in the blood (loss of appetite, muscle weakness, general malaise, etc.) accompanied by bone alterations (osteomalacia) especially with prolonged treatment.

At high doses, this medication may cause or worsen intestinal obstruction, especially in patients with kidney disease, intestinal disorders, and the elderly.

If you have mild to moderate kidney disease and need to take this medication, use it with caution and avoid prolonged use, as it may cause: central nervous system alterations, a decrease in the number of red blood cells in the blood, or worsening of bone diseases.

It is not recommended to use antacids containing aluminium in patients with Alzheimer's disease, as it may contribute to the development of the disease.

In elderly patients, the continued use of antacids containing aluminium may exacerbate existing bone diseases.

If you have porphyria (a group of hereditary disorders that involve anomalies in the production of the pigment of red blood cells) and are undergoing haemodialysis (a process to remove waste products from the blood when the kidneys are unable to do so), consult your doctor before taking this medication.

Inform your doctor of the appearance of any symptoms indicating bleeding, such as black stools or coffee-ground vomit.

Interference with diagnostic tests:

If you are to undergo any diagnostic test (including blood, urine, or radioactive tracer tests), inform your doctor that you are taking this medication, as it may alter the results.

If you are to undergo a test to evaluate the secretory function of the stomach acid, do not take antacids on the same morning as the test.

Children:

It is not recommended to use antacids in children under 12 years old, as they may mask symptoms of existing diseases (e.g. appendicitis). In young children, there is a risk of increased magnesium levels in the blood or aluminium toxicity, especially if they are dehydrated or have kidney disease.

Taking ACYLINE with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Antacids may modify the action of other medications, so you should separate the taking of any antacid from other medications.

It is essential to inform your doctor if you are taking any of the following medications:

• Antagonists H2 (medications used to treat digestive problems)
• Atenolol, propranolol, metoprolol (medications used to treat heart problems and hypertension)
• Chloroquine (used to treat malaria)
• Diflunisal (non-steroidal anti-inflammatory)
• Bisphosphonates (used to treat osteoporosis)
• Antibiotics (lincosamides, tetracyclines, fluoroquinolones, azithromycin, cefdinir, cefpodoxime)
• Ketoconazole (used to treat fungal infections)
• Penicillamine (used to treat rheumatic diseases)
• Kayexalate (used to treat high potassium levels in the blood)
• Digoxin (used to treat heart problems)
• Ethambutol, isoniazid, rifampicin (used to treat tuberculosis)
• Sodium fluoride (disinfectant)
• Glucocorticoids (prednisone)
• Indomethacin (anti-inflammatory)
• Neuroleptics (used to treat mental disorders)
• Iron salts (used to treat anemia)
• Antihypertensive medications (captopril, fosinopril)
• Levothyroxine (used to treat thyroid problems)
• Rosuvastatin (used to lower cholesterol levels in the blood)
• Methenamine (used to eliminate bacteria from the urinary tract)

• Mecamilamine (used to reduce blood pressure)
• Phenytoin (used to treat seizures)
• Amphetamines (used as a potent stimulant of the central nervous system)
• Sodium phosphate of cellulose (used to prevent the formation of kidney stones)
• Quinidine (used to treat heart problems)

• Sodium citrate (used to treat kidney stones and other kidney problems, dehydration, diarrhea)
• Salicylates (acetylsalicylic acid, used to treat inflammation, pain, and fever)
• Sucralfate (used to treat ulcers)

In all these cases, it is recommended to leave a 2-hour gap between taking any of these medications and taking ACYLINE (4 hours in the case of fluoroquinolones) to avoid unwanted interactions.

Antacids may destroy the coating of some oral medications (coating that some medications have to prevent them from dissolving in the stomach).

Pregnancy and breastfeeding:

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

The consumption of this medication during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

It is recommended to avoid chronic or excessive use of ACYLINE during pregnancy.

Driving and operating machinery:

ACYLINE does not affect the ability to drive or operate machinery.

ACYLINE contains:ethanol (96%):

This medication contains 0.6% ethanol (96%), which corresponds to 60 mg per dose, equivalent to 1.2 ml of beer or 0.5 ml of wine.

This medication is hazardous to individuals with alcoholism.

The alcohol content should be taken into account in the case of pregnant women, breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

Follow exactly the administration instructions for ACYLINE contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose in adults and those 12 years of age and older is half to one sachet of oral suspension (5ml to 10ml) four times a day, when symptoms appear, 20 minutes to one hour after the three main meals and before going to bed.

Use in children

Do not administer this medication to children under 12 years of age.

This medication is taken orally.

Press the sachet several times before opening it to ensure complete homogenization of the suspension. ACYLINE can be taken directly from the sachet or the contents can be poured into half a glass of water. Stir and take afterwards.

Do not take more than 4 sachets per day.

If symptoms do not improve in 14 days, discontinue treatment and consult a doctor.

If you take more ACYLINE than you should

At the recommended doses, it is unlikely to experience an overdose with this medication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to takeACYLINE

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The observed adverse effects are generally mild and transient.

If you experience the following adverse effects, stop taking the medication and consult your doctor: allergic reactions such as pruritus (itching), urticaria (hives, skin irritation, and itching), angioedema (generalized urticaria accompanied by inflammation of the feet, hands, throat, lips, and respiratory tract), these adverse reactions are of unknown frequency (cannot be estimated from available data).

Other adverse effects that may occur are:

- Infrequent(may affect up to 1 in 100 patients):constipation, diarrhea, orregurgitation.

- Unknown frequency(cannot be estimated from available data):

- hypermagnesemia (when your blood magnesium levels are elevated)

- hyperaluminemia (when your blood aluminum levels are elevated)

- hypophosphatemia (when your blood phosphorus levels are decreased).

In cases of prolonged use or in patients with low-phosphorus diets, kidney stones and bone diseases may occur.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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.

No special storage conditions are required.

Do not use ACYLINE if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of ACYLINE

The active principles are: Algeldrate 620 mg, Magnesium hydroxide 380 mg, Aluminum hydroxide-magnesium carbonate, coprecipitated 630 mg.

The other components (excipients) are:Sucralose (E-955), Ethanol (96 percent), Chlorhexidine acetate, Hydroxyethylcellulose, Peppermint aroma and Purified water. See section 2 “ACYLINE contains ethanol (96 percent)”

Appearance of the product and contents of the packaging

ACYLINE is presented in the form of a white suspension.

Each package contains 20 sachets with 10 ml of suspension

Holder of the marketing authorization and responsible for manufacturing

ARAFARMA GROUP S.A.

C/ Fray Gabriel de San Antonio 6-10

Pol. Ind. Henares

19180 Marchamalo, Guadalajara

Email:[email protected]

Telephone: 949 22 56 22

Last review date of this leaflet: March 2014

The detailed and updated information on this medicine is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/