Controloc Control 20mg (14 Tablets)

CONTROLOC Control is indicated for the short-term treatment of symptoms of gastro-oesophageal reflux disease (e.g. heartburn, regurgitation) in adults.
Active substance: Pantoprazole

Composition

1 gastro-resistant tablet contains 20 mg of pantoprazole (as sodium pantoprazole

one and a half water).

For a full list of excipients, see section 6.1.

Dosage

The recommended dose is 20 mg pantoprazole (1 tablet) once a day.

It may be necessary to use the medicine for another 2-3 days to obtain relief of symptoms. Treatment should be discontinued when symptoms have completely disappeared. Treatment should not exceed 4 weeks without consulting a doctor.

Patients should be instructed to consult a physician if symptoms persist within 2 weeks of treatment.

Special patient groups

No dosage adjustment is necessary in elderly patients or in patients with renal or hepatic impairment.

Children and youth

CONTROLOC Control should not be used in children and adolescents under 18 years of age due to limited data collected on safety and efficacy.

Method of administration

CONTROLOC Control 20 mg gastro-resistant tablets should not be chewed or crushed. They should be taken before a meal, swallowed whole with water.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Co-administration with atazanavir (see section 4.5).

Contents

Al / Al blisters with or without cardboard reinforcement containing 14 gastro-resistant tablets.

Storage method

15°C-25°C

Manufacturer

TAKEDA

Warnings

The patient should contact a doctor in the event of:

•   Weight loss not due to intentionally weight loss, anemia, gastrointestinal bleeding, dysphagia, persistent or bloody vomiting. Treatment with pantoprazole may alleviate the symptoms of a severe disease and delay diagnosis. In these cases, it is necessary to exclude the neoplastic origin of the disease.

•   Have a history of gastric ulcer or gastrointestinal surgery.

•   Relief of symptoms of indigestion or heartburn for a continuous period of more than 4 weeks.

•   Jaundice, dysfunction or liver disease.

•   Other serious illnesses affecting your general well-being.

•   If you are over 55 years of age and have new symptoms or the nature of the symptoms you are already seeing has changed.

Patients with long-term, recurring symptoms of indigestion or heartburn should be monitored regularly. In particular, patients over 55 years of age using non-prescription indigestion or heartburn remedies on a daily basis should inform their doctor or pharmacist.

Patients should not use other proton pump inhibitors or histamine H ₂ antagonists concurrently .

Patients who are due to have an endoscopy or urease test should consult their physician before taking this medicinal product.

Patients should be informed that the drug is not intended to relieve symptoms immediately. Symptoms may be relieved after approximately one day of pantoprazole use. You may need to use it for 7 days for complete heartburn relief. Patients should not take pantoprazole as a preventive measure.

Reducing gastric acidity, for whatever reason, including through the use of proton pump inhibitors, increases the amount of bacteria normally present in the gastrointestinal tract. The use of acid-reducing drugs leads to a slightly increased risk of gastrointestinal infections such as Salmonella , Campylobacter or C. difficile infection.

Pregnancy
There are no adequate data on the use of pantoprazole in pregnant women. Animal studies have shown reproductive toxicity. There was no evidence of impaired fertility or teratogenicity in preclinical studies (see section 5.3). The potential risk for humans is unknown. CONTROLOC Control is contraindicated during pregnancy.

Breast-feeding
There are no data on the excretion of pantoprazole in human breast milk. Animal studies have shown excretion of pantoprazole in milk. CONTROLOC Control is contraindicated during breast-feeding.

Fertility
Animal studies have shown no impairment of fertility following the administration of pantoprazole (see section 5.3).

Driving vehicles
CONTROLOC Control has no or negligible influence on the ability to drive and use machines.

Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). In such cases, patients should refrain from driving or operating machinery.

Overdosage

There are no known symptoms of overdose in humans.

Doses up to 240 mg administered intravenously over 2 minutes were well tolerated.

As pantoprazole is extensively bound to plasma proteins, it is difficult to dialysate.

In the event of an overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.

Interactions with other drugs

CONTROLOC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).

Co-administration of 300 mg atazanavir / 100 mg ritonavir with omeprazole (40 mg daily) or 400 mg atazanavir with lansoprazole (60 mg single dose) has been shown to significantly reduce the bioavailability of atazanavir to healthy volunteers. The absorption of atazanavir is pH dependent. Therefore, pantoprazole should not be co-administered with atazanavir (see section 4.3).

Pantoprazole is metabolised in the liver with the participation of the cytochrome P-450 enzyme system. An interaction of pantoprazole with other substances which are metabolised via the same enzyme system cannot be excluded. No clinically significant interactions were found in specific tests performed with: carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and ethinylestradiol containing oral contraceptives.

Based on the pharmacokinetic studies performed, no interaction was found between pantoprazole and phenprocoumon or warfarin. However, after introducing the product to the market in individual cases, changes in the value of the international normalized ratio – INR were observed during their simultaneous use. Therefore, in patients treated with anticoagulants with coumarin derivatives (e.g. phenprocoumon or warfarin), it is recommended to monitor the prothrombin time (INR) after initiation, termination or during irregular use of pantoprazole.

In some patients it has been observed that the concomitant use of high doses of methotrexate (e.g. 300 mg) with proton pump inhibitors led to increased levels of methotrexate. Therefore, temporary discontinuation of proton pump inhibitors should be considered in patients on high doses of methotrexate, e.g. in cancer or psoriasis.

There were no interactions with concomitantly administered antacids.

Side effects

Approximately 5% of patients are expected to experience side effects. The most frequently reported adverse reactions occurring in approximately 1% of patients are diarrhea and headache. The following side effects have been reported with pantoprazole.

In the table below, adverse reactions are ranked under the frequency classification

MedDRA:

Very common (≥1 / 10); Common (≥1 / 100 to <1/10); Uncommon (≥1 / 1,000 to <1/100); Rare (≥1 / 10,000 to <1 / 1,000); Very rare (≤1 / 10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table No. 1. Adverse reactions with pantoprazole in clinical trials and post-marketing

The frequency of occurrence System organ classification	Not so often	Rarely	Very rarely	Unknown
Blood and the lymphatic system disorders		Agranulocytosis	Thrombocytopenia; Leukopenia, Pancytopenia
Nervous system disorders	Headaches; Dizziness	Taste disturbance
Eye disorders		Visual disturbance / blurred vision
Disorders stomach and intestines	Diarrhea; Nausea / vomiting; A feeling of fullness in the abdomen and flatulence; Constipation; Dry mouth; Abdominal pain and discomfort
Renal and tract disorders urinary				Interstitial nephritis
Skin and subcutaneous tissue disorders	Rash skin / Erythema / Skin eruptions; Itching	Hives; Angioedema		Stevens-Johnson syndrome; Lyell’s syndrome; Erythema multiforme; Hypersensitivity to light
Disorders musculoskeletal and connective tissues		Arthralgia; Muscle aches
Metabolism and nutrition disorders		Hyperlipidemia and increased lipid levels (triglycerides, cholesterol); Weight change		Hyponatremia, Hypomagnesaemia
General disorders and conditions in	Weakness, fatigue and bad	Increase in body temperature;
application site	well-being	Edema peripheral
Immune system disorders		Hypersensitivity (including anaphylactic reactions and anaphylactic shock)
Disorders liver and biliary tract	Increased liver enzymes (transaminases, γ-GT)	Increase in bilirubin		Damage liver cells; Jaundice; Liver cell failure
Mental disorders	Sleep disturbance	Depression (and mental deterioration)	Confusion (and mental deterioration)	Hallucinations, confusion (especially in susceptible patients like also the worsening of similar symptoms with them earlier occurrence)
Reproductive system and breast disorders		Gynecomastia