Ranloc

1. What Ranloc is and what it is used for

Ranloc contains the active substance pantoprazole. It is a selective proton pump inhibitor, a medicine which reduces the amount of acid produced in the stomach. It is used for treating diseases of the stomach and gut where too much acid is produced.

Ranloc is used for adults and adolescents 12 years of age and older for:

• Gastro-oesophageal reflux disease. This is where the acid in the stomach flows back up into the gullet (the tube that carries food from the mouth to the stomach), causing pain and discomfort.

Ranloc is used for adults for:

• Infection with a bacterium called Helicobacter pylori in patients with duodenal and/or gastric ulcers, in combination with two antibiotics (eradication therapy), to get rid of the bacterium and prevent recurrence of ulcers.
• Ulcers of the stomach and/or duodenum.
• Zollinger-Ellison syndrome and other conditions where too much acid is produced in the stomach.

2. What you need to know before you take Ranloc

Do not take Ranloc

• If you are allergic to pantoprazole or any of the other ingredients of this medicine.
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

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Before you start taking Ranloc, tell your doctor or pharmacist:

• If you have severe liver problems. You should also tell your doctor if you have ever had problems with your liver in the past. Your doctor may need to monitor your liver function more closely while you are taking this medicine. If you have severe liver disease, your doctor may need to reduce the dose or tell you not to take Ranloc.
• If you have a vitamin B12 deficiency. Pantoprazole, like other proton pump inhibitors, may reduce the absorption of vitamin B12.
• If you are taking a medicine called atazanavir (used to treat HIV infection). If you are taking atazanavir, you should not take Ranloc because it may make atazanavir less effective.
• If you are over 55 and have a history of osteoporosis (thinning of the bones), or have other risks for osteoporosis (such as taking steroid medicines, lack of calcium and/or vitamin D, smoking, or excessive drinking), or have had a fracture of the spine, hip or wrist. Your doctor may advise you to have a bone density test and may prescribe calcium and vitamin D supplements as additional treatment.
• If you are due to have a specific blood test (Chromogranin A).

Tell your doctor immediatelybefore or during treatment if you notice any of the following symptoms, which could be a sign of a more serious condition:

• Unintentional weight loss
• Vomiting (particularly when vomiting blood)
• Black (blood-stained) stools or blood in stool
• Difficulty swallowing or pain when swallowing
• Pale or weak skin (anaemia)
• Chest pain
• Severe abdominal (stomach) pain
• Severe and/or persistent diarrhoea, as this medicine has been associated with a small increased risk of infectious diarrhoea.

Your doctor may decide to perform some tests to rule out malignant disease (cancer), because pantoprazole may mask the symptoms of cancer and therefore delay its diagnosis. If your symptoms persist despite taking pantoprazole, further investigations will be needed.

Children and adolescents

Ranloc is not recommended for children under 12 years of age.

Other medicines and Ranloc

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), because Ranloc may stop these and other medicines from working properly.
• Warfarin and phenprocoumon, which are medicines used to thin the blood. Your doctor may need to monitor your blood more closely when you are taking these medicines with Ranloc.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer), because pantoprazole may increase the levels of methotrexate in the blood.
• Fluvoxamine (used to treat depression and other psychiatric diseases), because it may increase the levels of pantoprazole in the blood.
• Rifampicin (used to treat tuberculosis).
• St John’s Wort (Hypericum perforatum), because it may decrease the levels of pantoprazole in the blood.

Pregnancy and breast-feeding

There is limited experience with the use of pantoprazole during pregnancy. Pantoprazole has been shown to pass into the breast milk of animals.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ranloc should only be used during pregnancy if the benefits to the mother outweigh the risks to the baby.

Driving and using machines

Ranloc has no or negligible influence on the ability to drive and use machines.

However, do not drive or use machines if you feel dizzy or have other side effects that affect your ability to do these activities.

Ranloc contains sodium

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This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Ranloc

Take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

Take one tablet each day, except when taking Ranloc in combination with antibiotics (see below). Take the tablet 1 hour before a meal without chewing or crushing it, and swallow it whole with some water.

Adults and adolescents 12 years of age and older

• - For the treatment of gastro-oesophageal reflux diseaseThe usual dose is one tablet per day. Your doctor may increase the dose to two tablets per day. The treatment duration for gastro-oesophageal reflux disease is usually 4 to 8 weeks. Your doctor will tell you how long to take your medicine.

Adults

• - For the treatment of Helicobacter pylori infection in combination with two antibiotics (eradication therapy)One tablet twice a day plus two tablets of antibiotics (amoxicillin, clarithromycin or metronidazole (or tinidazole)) each taken twice a day with the pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before dinner. Follow your doctor’s instructions and read the package leaflet for the antibiotics.
• - For the treatment of stomach and/or duodenal ulcersThe usual dose is one tablet per day. After consulting your doctor, the dose may be doubled. Your doctor will tell you how long to take your medicine. The treatment duration for stomach ulcers is usually 4 to 8 weeks. The treatment duration for duodenal ulcers is usually 2 to 4 weeks.

In long-term treatment of Zollinger-Ellison syndrome and other conditions where too much acid is produced in the stomach
The recommended starting dose is usually two tablets per day. Both tablets should be taken 1 hour before a meal. Your doctor may later adjust the dose depending on the amount of acid in your stomach. If your doctor prescribes more than two tablets per day, you should take them twice a day.

Patients with kidney problems

Do not take Ranloc for the eradication of Helicobacter pylori if you have kidney problems.

Patients with liver problems

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In severe liver disease, a maximum of one 20 mg pantoprazole tablet per day should be taken (lower dose tablets are available). Ranloc should not be used for the eradication of Helicobacter pylori in moderate to severe liver disease.

Use in children and adolescents

Tablets are not recommended for children under 12 years of age.

If you take more Ranloc than you should

Consult your doctor or pharmacist. There are no known symptoms of overdose.

If you forget to take Ranloc

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you stop taking Ranloc

Do not stop taking Ranloc without first talking to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following side effects, stop taking Ranloc and tell your doctor immediately or contact the casualty department at your nearest hospital:

• - Severe allergic reactions(rare: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty in swallowing, hives, difficulty in breathing, anaphylactic shock, allergic facial oedema (Quincke’s oedema), severe dizziness with rapid heartbeat and heavy sweating.
• - Severe skin reactions(frequency not known: cannot be estimated from the available data): blistering of the skin and/or mucous membranes, severe skin reactions including Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, and toxic epidermal necrolysis, and DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms).
• - Other severe reactions(frequency not known: cannot be estimated from the available data): yellowing of the skin or eyes (severe liver disorder, jaundice), fever, rash, and a painful joint (inflammation of the kidneys), which may be signs of a severe infection.

Other side effects include:

• - Common(may affect up to 1 in 10 people): mild polyps in the stomach.
• - Uncommon(may affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; feeling bloated, wind, and/or abdominal distension; constipation; dry mouth; abdominal pain and discomfort; skin rash, itching, exanthema/dematitis, and/or pruritus; fatigue, malaise, and/or asthenia; sleep disorders; fractures of the hip, wrist or spine.
• - Rare(may affect up to 1 in 1,000 people): changes in taste or loss of taste; changes in vision, such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; increased temperature; high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.
• - Very rare(may affect up to 1 in 10,000 people): disorientation.
• - Frequency not known(cannot be estimated from the available data): hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood; decreased magnesium levels in the blood (see section 2); feeling of tingling or numbness in the hands and feet; rash, possibly with a high temperature and enlarged lymph nodes (DRESS syndrome); severe skin reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis; inflammation of the colon (colonopathy); low levels of zinc in the blood.

Side effects with frequency not known

• - Increased liver enzymes in the blood
• - Increased bilirubin in the blood
• - Increased fats in the blood
• - Decreased white blood cells
• - Decreased platelets
• - Decreased sodium, magnesium, calcium, or potassium levels in the blood

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Ranloc

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• 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 and blister after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Bottle: Ranloc should be used within 100 days after opening.
• 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 protect the environment.

6. Contents of the pack and other information

What Ranloc contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).

The other ingredients are:

Core of the tablet:sodium carbonate anhydrous, mannitol, crospovidone Type A, hydroxypropylcellulose, microcrystalline cellulose, calcium stearate

Coating of the tablet:Opadry 02H52369 Yellow: hypromellose, propylene glycol, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172)

Enteric coating:methacrylic acid - ethyl acrylate copolymer (1:1), triethyl citrate, sodium lauryl sulfate, titanium dioxide (E 171), talc, yellow iron oxide (E 172)

What Ranloc looks like and contents of the pack

The gastro-resistant tablets are yellow, oval, biconvex, film-coated, smooth on both sides.

Ranloc is available in packs of 7, 14, 28, 60, and 90 gastro-resistant tablets in blisters, and 60 or 100 gastro-resistant tablets in HDPE bottles. Each bottle contains one desiccant sachet with silica gel. DO NOT EAT THE DESICCANT.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warszawa

Manufacturer

Terapia S.A.
124 Fabricii Street, 400632 Cluj-Napoca
Romania
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Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp,
Netherlands
Alkaloida Chemical Company Zrt.
H-4440, Tiszavasvári,
Kabay János u. 29.
Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany
PANTOPRAZOL BASICS 40 mg magensaftresistente Tabletten
Italy
Pantoprazolo Sun Pharmaceutical Industries Limited
Spain
Pantoprazol SUN 40mg comprimidos gastrorresistentes EFG

Date of revision of the leaflet: 18.10.2023