Geffer: detailed information

Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor
or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

What Geffer is and what it is used for
What you need to know before taking Geffer
How to take Geffer
Possible side effects
How to store Geffer
Contents of the pack and other information

1. What Geffer is and what it is used for

Geffer belongs to the therapeutic category of prokinetics (medicines that accelerate gastric emptying): it is a combination medicine intended for the treatment of disorders arising from gastric hyperacidity (excess acid in the stomach), overeating, abnormal presence of air and gas in the stomach, and digestive difficulties.
Geffer is used to treat symptoms of hyperacidity (stomach pain and burning), when accompanied by delayed gastric transit (slow digestion), nausea, aerophagia, and meteorism (conditions characterized by abnormal accumulation of gas in the stomach or intestine, leading to belching, abdominal tension, and bloating).
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before taking Geffer

Do not take Geffer

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
if you are under 16 years of age (see "Children and adolescents");
if you are taking medicines belonging to the group of anticholinergics (medicines that inhibit the effects of acetylcholine, a neurotransmitter);
in cases where stimulation of intestinal motility could be dangerous, for example in the presence of gastrointestinal bleeding, perforation, or mechanical obstruction (blockage of the intestinal tract);
if you suffer from any of the following conditions: glaucoma (an eye disease characterized by increased intraocular pressure), pheochromocytoma (a tumor of the adrenal gland),

epilepsy,
Parkinson's disease and other extrapyramidal disorders (involuntary movement disorders),
porphyria, a rare disease in which the activity of certain enzymes is impaired,
metabolic or respiratory alkalosis (conditions in which blood pH rises above normal),
hypocalcemia (low levels of calcium in the blood).

Warnings and precautions

Talk to your doctor or pharmacist before taking Geffer.

If you are elderly, do not exceed 3 consecutive days of treatment and follow the minimum dosage recommendations (see "How to take Geffer" and "Possible side effects").

Stop treatment and contact your doctor or pharmacist immediately if, during treatment with Geffer, you experience any of the following symptoms: high fever, high blood pressure, seizures, sweating, or excessive salivation. These may be signs of a disorder called neuroleptic malignant syndrome.

High doses or prolonged use of Geffer may cause metabolic or respiratory alkalosis (alterations in blood pH).

Consult your doctor before taking Geffer:

if you suffer from hypokalemia (low potassium levels in the blood), as this medicine may worsen alkalosis;
if you have conditions causing edema (fluid retention in the body), such as congestive heart failure or reduced kidney function;
if you suffer from hyperaldosteronism (excessive production of the hormone aldosterone);
if you have kidney problems (renal insufficiency).

Children and adolescents

Geffer must not be administered to children under 16 years of age (see "Do not take Geffer").

Other medicines and Geffer

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Avoid taking neuroleptics (antipsychotic medicines, e.g. phenothiazines, butyrophenones, thioxanthenes, etc.) and sedatives (tranquilizers) at the same time as Geffer.

The sedative effects of central nervous system depressants (morphine derivatives, hypnotics, anxiolytics, sedative antihistamines, sedative antidepressants, barbiturates, etc.) and of metoclopramide are enhanced.

The metoclopramide contained in Geffer increases the effects of monoamine oxidase inhibitors (used in depression), sympathomimetics (used, for example, to raise blood pressure), and tricyclic antidepressants.

Due to the intestinal transit-accelerating effect of metoclopramide contained in Geffer, the absorption of certain medicines may be altered.

Metoclopramide may reduce blood levels of digoxin (used in heart failure), while increasing those of cyclosporine (used to prevent organ transplant rejection).

It reduces the central nervous system effects of apomorphine (used in Parkinson's disease and erectile dysfunction).

It reduces blood levels of cimetidine (a medicine used for ulcers), though without significantly affecting its efficacy.

Metoclopramide interacts with serotonergic medicines (e.g. selective serotonin reuptake inhibitors, used for depression), increasing the risk of serotonin syndrome (a serious form of poisoning).

The sodium bicarbonate contained in Geffer may:

reduce the absorption of antibiotics such as tetracyclines (especially doxycycline) and ketoconazole (an antifungal medicine);
increase the renal elimination of salicylates (such as acetylsalicylic acid), barbiturates, and lithium (medicines acting on the nervous system);
reduce the renal elimination of ephedrine, amphetamines (medicines acting on the nervous system), quinidine, and flecainide (medicines that regulate heart rhythm).

The citrate salts contained in Geffer may increase gastrointestinal absorption of aluminum. This should be particularly considered in patients with reduced kidney function who are taking aluminum salts (antacid medicines).

Take Geffer at least 2 hours apart from any other medicine to avoid interfering with its activity.

Geffer with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment with Geffer, as alcohol enhances the sedative effects of metoclopramide.

During treatment with Geffer, avoid large amounts of food (such as milk and dairy products) or products containing calcium, due to the risk of milk-alkali syndrome (characterized by increased calcium levels and elevated body pH).

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, do not take this medicine.

Inform your doctor or pharmacist before taking any medicine.

Driving and using machines

This medicine, particularly at high doses, may cause disturbances that could impair alertness. Bear this in mind when driving or operating potentially dangerous machinery.

Geffer contains sodium

This medicine contains 288 mg of sodium (the main component of table salt) per sachet. This corresponds to 14.4% of the maximum recommended daily dietary sodium intake for an adult.

Geffer contains sucrose

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

3. How to take Geffer

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The use of this product is restricted to adult patients.
The recommended dose is: 1 sachet dissolved in half a glass of water, 2–3 times daily.
Do not exceed the recommended doses without medical advice. In particular, elderly patients should adhere to the lower doses indicated above (see "Warnings and precautions" and "Possible side effects").
Geffer should be taken before meals or at the onset of symptoms.
Warning: If there is no noticeable improvement after a maximum of 3 days of treatment, consult your doctor.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.
If you take more Geffer than you should
In case of accidental ingestion or overdose of Geffer, contact your doctor immediately or go to the nearest hospital.
Metoclopramide may cause disturbances in consciousness such as drowsiness and disorientation, and involuntary movements may also occur, mainly affecting the muscles of the limbs.
Prolonged use of metoclopramide may cause galactorrhoea (milk secretion in males or in females who are not breastfeeding) and amenorrhoea (absence of menstruation).
An overdose of sodium bicarbonate may cause metabolic alkalosis, which in severe cases may be associated with hyperirritability and/or tetany (muscle spasms and cramps).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse effects due to the presence of metoclopramide in the medicine:

Uncommon (may affect up to 1 in 100 patients):
visual disturbances and involuntary deviation of the eye
Rare (may affect up to 1 in 1,000 patients):
hyperprolactinaemia (increased blood levels of prolactin, a hormone secreted by endocrine glands);
menstrual cycle disturbances;
galactorrhoea (milk secretion in male subjects or in women who are not breastfeeding);
gynaecomastia (development of breasts in males);
somnolence;
fatigue;
dizziness;
porphyria (a rare disorder in which the activity of certain enzymes is altered);
various types of extrapyramidal reactions, usually dystonic in nature. These may include facial spasms, trismus (jaw spasm preventing mouth opening), and abnormal head positions; such reactions usually resolve within 24 hours after discontinuation of treatment.

In patients with phaeochromocytoma (a tumour of the adrenal gland), hypertensive crises, sometimes fatal, have been reported; therefore, the use of Geffer is contraindicated in these patients (see "Do not take Geffer").
In some elderly patients undergoing prolonged treatment, tardive dyskinesia (a severe extrapyramidal-type reaction characterised by involuntary body movements), potentially irreversible, has been reported; therefore, elderly patients must strictly avoid treatments exceeding 3 days in duration.

Frequency not known (frequency cannot be estimated from the available data):
high fever, high blood pressure, seizures, sweating, salivation. These may be symptoms of a condition called neuroleptic malignant syndrome (see "Warnings and precautions")
Very high blood pressure

Adverse effects due to the presence of citrate salts in the medicine:

Frequency not known (frequency cannot be estimated from the available data): Gastrointestinal disorders Oral administration of excessive doses of citrate salts may have a laxative effect.

Adverse effects due to the presence of sodium bicarbonate in the medicine:

Frequency not known (frequency cannot be estimated from the available data): Metabolism and nutrition disorders Reduction in potassium levels in the blood (hypokalaemia), increase in sodium levels in the blood (hypernatraemia), metabolic alkalosis (symptoms may include shortness of breath, muscular effects such as weakness, muscle hypertonicity, involuntary contractions, muscle spasms, especially with reduced calcium levels, and effects on the central nervous system). Following the instructions in the package leaflet reduces the risk of adverse effects. These adverse effects are generally transient. However, if they occur, it is advisable to consult a doctor or pharmacist.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse effects directly through the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Geffer

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and carton.
The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Geffer contains

The active substances are: metoclopramide hydrochloride, dimethicone, potassium citrate, citric acid, tartaric acid, sodium bicarbonate. Each effervescent granule sachet contains metoclopramide hydrochloride 5 mg, dimethicone 50 mg, potassium citrate 94.45 mg, citric acid 670 mg, tartaric acid 152 mg, sodium bicarbonate 1050 mg.
The other components are: orange flavour, sucrose.

Description of the appearance of Geffer and the contents of the pack
Geffer is an orange-flavoured effervescent granule presented in single-dose sachets.
Pack contents: 24 sachets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa 130 - 20156 Milan
Manufacturer
Doppel Farmaceutici S.r.l
Via Volturno 48 – Quinto De’ Stampi
20089 Rozzano (Mi)