500 mg / 213 mg / 325 mg oral suspension in sachet
sodium alginate, sodium bicarbonate, calcium carbonate
1. What Galieve is and what it is used for
Galieve is a combination drug of two substances that reduces the acidity of the stomach
( calcium carbonate and sodium bicarbonate) and alginate. It works in two ways:
1. by neutralizing an excessive acid production in the stomach which relieves pain and discomfort.
2. by forming a protective layer on top of the stomach contents which relieves burning sensation ii up to 4 hours.
This medicine is used to treat acid-related symptoms of gastroesophageal reflux disease, such as acid reflux, heartburn, and indigestion, for example after meals and during pregnancy.
2. What you need to know before using Galieve
Do not take Galieve
- if you know that you are allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Galieve if you:
- have severe renal impairment .
- have disturbances in the electrolyte balance (salt balance) that cause low phosphate levels in the blood ( hypophosphatemia ).
- have or have had significant kidney or heart disease , as some salts can affect these diseases (talk to your doctor about the salt content).
- know that you have a reduced amount of stomach acid in your stomach , as the effect of this medicine may then be weaker.
Like other medicines that reduce the acidity of the stomach, Galieve can also hide symptoms of other more serious diseases.
If symptoms persist after 7 days, consult your doctor.
Children
Do not give this medicine to children under 12 years of age without the advice of a doctor.
There is a risk of increased sodium levels in the blood ( hypernatremia ) in children who have kidney problems or who have an inflammation of the stomach or intestines ( gastritis ).
Other medicines and Galieve
Do not take other medicines taken by mouth at least two hours after or before Galieve, as Galieve may affect the effectiveness of other medicines. Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding and fertility
You can use this medicine during pregnancy and lactation and if you are planning to have a baby. As with all medicines, the duration of treatment should be as short as possible.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Galieve contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed). It also contains 127.88 mg (5.56 mmol) of sodium per 10 l / l sachet dose. The maximum daily dose of sodium in this medicine contains 1023 mg of sodium (the main ingredient in table salt (table salt)), which corresponds to 51.15% of the maximum recommended daily intake of sodium for adults. for a long time, especially if you have been instructed to follow a diet with restrictions in sodium intake.
It also contains 130 mg (3.25 mmol) of calcium per dose. Talk to your doctor before using this medicine if you have kidney stones or high calcium levels in your blood.
3. How to use Galieve
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Adults, the elderly, and children aged 12 or over
10–20 ml (1-2 sachets) after meals and at bedtime, no more than four times a day.
Children under 12 years: Only according to the doctor’s prescription.
If you take more Galieve than you should
It is unlikely that you will experience any side effects if you take too much of the medicine. However, you may feel bloated.
Consult a doctor if this does not go away.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Galieve
If you forget to take a dose, do not take a double dose next time. Just take the next dose as usual.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. In very rare cases (in less than 1 in 10,000 users) an allergic reaction to the ingredients of the medicine may occur. Symptoms may include stomach pain, diarrhea, nausea, vomiting, itchy skin, rash, itching, dizziness, swelling of the face, lips, tongue, or throat, and difficulty breathing.
Intake of large amounts of calcium carbonate (which is an ingredient in this medicine) can increase the pH of the blood ( alkalosis ), make the calcium level in the blood too high ( hypercalcemia ), increase the secretion of stomach acid and cause constipation. These usually occur if the recommended doses are exceeded.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Galieve
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP (month/year). The expiration date is the last day of the specified month.
Do not store above 30 ° C. Store in a cold place. Do not freeze.
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 packaging and other information
Content declaration
The active substances are sodium alginate, sodium bicarbonate, and calcium carbonate. Each 10 ml sachet contains 500 mg of sodium alginate, 213 mg of sodium bicarbonate, and 325 mg of calcium carbonate. The other ingredients are carbomer 974P, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, peppermint flavor, sodium hydroxide, and purified water.
What the medicine looks like and contents of the pack
Galieve oral suspension is an off-white suspension with a taste and aroma of peppermint.
Galieve is available in packs of 4, 12, 24, and 48 sachets, as well as in multipacks of 48 (2 x 24) sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Scandinavia) A / S
Vandtårnsvej 83A
2860 Søborg
Denmark
Tel .: +45 4444 9701
Manufacturer
RB NL Brands BV
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands