Starab

Package leaflet: Information for the patient

STARAB 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets

rabeprazole
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What STARAB is and what it is used for
2. What you need to know before taking STARAB
3. How to take STARAB
4. Possible side effects
5. How to store STARAB
6. Contents of the pack and other information

1. What STARAB is and what it is used for

STARAB belongs to a group of medicines called proton pump inhibitors (PPIs).
STARAB works by reducing the amount of acid produced in the stomach.
STARAB is used to treat:

• ulcers in the upper part of the intestine (duodenal ulcer) and benign gastric ulcers.
• Gastroesophageal reflux disease (GERD), with or without ulceration. Gastroesophageal reflux disease is commonly described as inflammation of the oesophagus caused by acid, and is associated with heartburn. Heartburn is a burning sensation that starts in the stomach or lower chest and moves up towards the neck. STARAB can be used as long-term treatment (maintenance) of gastroesophageal reflux disease. STARAB can also be used for symptomatic treatment of moderate to very severe gastroesophageal reflux disease (symptomatic GERD).
• Zollinger-Ellison syndrome, a condition characterised by extremely high levels of acid production in the stomach.

In combination with two antibiotics (clarithromycin and amoxicillin), STARAB is used for
the eradication of H. pylori infection in patients with peptic ulcer. For further
information regarding the antibiotics used in H. pylori eradication therapy, refer to the respective
package leaflets.

2. What you need to know before taking STARAB

Do not take STARAB

• If you are allergic to sodium rabeprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking STARAB.

• If you are allergic to other proton pump inhibitors or "imidazole derivatives".
• If you have or have had any liver problems.
• If you have liver or blood problems; such problems have occurred in some patients and resolved upon discontinuation of treatment with STARAB.
• If you have been diagnosed with a stomach tumour.
• If you have low body stores or risk factors that reduce vitamin B12 absorption and are receiving long-term treatment with sodium rabeprazole. Like all other agents that reduce acid, sodium rabeprazole may lead to reduced absorption of vitamin B12.
• If you are taking a medicine called atazanavir (used to treat HIV).
• If you have ever had a skin reaction after treatment with a medicine similar to STARAB that reduces gastric acidity.
• If you are scheduled for a specific blood test (Chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with STARAB. Remember to also report any other adverse effects such as joint pain.
If any of these conditions apply to you, consult your doctor before taking STARAB.
If you develop severe diarrhoea (watery or with blood) with symptoms such as fever, abdominal pain or tenderness, stop taking STARAB and contact your doctor.
Your doctor may perform or may have already performed another examination called endoscopy to diagnose your condition and/or exclude malignant disease. The possibility of stomach or oesophageal tumours must be ruled out before starting treatment.
If you take STARAB for a long time (more than 1 year), your doctor will likely monitor you periodically. When you see your doctor, report any new or different symptoms you have noticed.
If you take a proton pump inhibitor such as STARAB, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
Abnormal blood test results have been reported during treatment with STARAB. Usually, values return to normal when treatment is stopped.
During treatment with rabeprazole, inflammation of the kidneys may occur. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must report such signs to your doctor.

Children
The use of STARAB is not recommended in children.

Other medicines and STARAB
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is particularly important that your doctor knows if you are taking any of the following medicines:

• atazanavir (used to treat HIV); taking STARAB is not recommended if you are taking atazanavir.
• ketoconazole or itraconazole (used to treat fungal infections).
• methotrexate (a chemotherapeutic agent used at high doses to treat tumours) – if you are taking a high dose of methotrexate, your doctor may temporarily discontinue your treatment with STARAB.

Pregnancy and breastfeeding
STARAB must not be used during pregnancy or breastfeeding.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is unlikely that STARAB will affect your ability to drive or use machines.
However, rabeprazole may occasionally cause drowsiness. Therefore, if you experience drowsiness, you should avoid driving or operating complex machinery.

STARAB contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take STARAB

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and elderly
Duodenal ulcers and benign gastric ulcers: 20 mg of STARAB once daily in the morning. Most patients with duodenal ulcer are treated for four weeks and most patients with benign gastric ulcer are treated for six weeks. However, some patients may require additional treatment to achieve healing.
Gastroesophageal reflux disease (GERD) with ulceration: 20 mg of STARAB once daily for four to eight weeks.
Long-term treatment of gastroesophageal reflux disease (GERD): 10 mg or 20 mg of STARAB once daily, depending on response.
Symptomatic treatment of gastroesophageal reflux disease: 10 mg of STARAB once daily for 4 weeks. Once symptoms have resolved, your doctor may instruct you to take 10 mg of STARAB once daily as needed for ongoing symptom control.
Zollinger-Ellison syndrome: 60 mg of STARAB once daily to start. The dose may subsequently be adjusted by your doctor depending on response to treatment. Your doctor will tell you how many tablets to take and when.
H. pylori eradication: 20 mg of STARAB twice daily, usually for 7 days (in combination with two antibiotics: clarithromycin and amoxicillin).

Patients with liver problems
You should consult your doctor, who will exercise particular caution at the start of your treatment with STARAB and throughout the therapy.

Use in children
STARAB is not recommended for use in children.

Instructions for use
The tablets should be swallowed whole with half a glass of water, without breaking or chewing them.
When taking STARAB once daily, the tablets should be taken in the morning before breakfast.

If you take more STARAB than you should
If you have taken more STARAB than prescribed by your doctor, consult your doctor.

If you forget to take STARAB
Do not take a double dose to make up for the forgotten dose. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait until then.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with STARAB and contact your doctor immediately if you notice any of the
following side effects – you may need urgent medical treatment:

• Allergic reactions – signs may include: sudden swelling of the face, shortness of breath or low blood pressure, which could lead to fainting or collapse.
• Frequent infections such as sore throat or fever or mouth or throat ulcers.
• Easy bruising or bleeding. These side effects are rare (occur in fewer than 1 in 1,000 people).
• Severe blistering skin reactions or irritation or mouth and throat ulcers. These side effects are very rare (occur in fewer than 1 in 10,000 people).

Common (may affect up to 1 in 10 people):

• cough, sore throat (pharyngitis), runny nose, cold symptoms
• nausea, vomiting, abdominal pain, diarrhoea, constipation, flatulence
• back pain, non-specific pain
• weakness or loss of strength, flu-like symptoms
• difficulty sleeping
• headache, dizziness
• infection
• benign gastric polyps

Uncommon (may affect up to 1 in 100 people):

• nervousness
• drowsiness
• inflammation of the bronchial tubes (bronchitis), inflammation of the sinuses (sinusitis)
• indigestion, dry mouth, burping
• skin rash, skin redness (erythema)
• muscle pain, joint pain, leg cramps
• urinary tract infection
• chest pain, chills, fever
• increased liver enzymes, measured by blood tests
• hip, wrist and spinal fractures

Rare (may affect up to 1 in 1,000 people):

• blood disorders such as reduced white blood cells or platelets. This may cause weakness, bruising or increased risk of infections
• increased number of white blood cells
• allergic reactions including facial swelling, low blood pressure and breathing difficulties
• loss of appetite
• depression
• changes in vision
• inflammation of the stomach or mouth, altered taste
• liver inflammation, jaundice (yellowing of the skin or eyes)
• itching, sweating, skin blisters
• kidney inflammation (interstitial nephritis)
• weight gain

Very rare (may affect up to 1 in 10,000 people):

• sudden onset of severe skin rash, blistering or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)).

Not known (frequency cannot be estimated from the available data):

• low levels of sodium in the blood, which may lead to tiredness, confusion, muscle spasms, seizures and coma
• confusion
• fluid retention
• swelling of the feet and ankles
• breast enlargement in men
• erythema, possible joint pain
• inflammation of the intestine (causing diarrhoea)
• brain disorder associated with liver failure (hepatic encephalopathy)

If you take STARAB for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.

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

5. How to store STARAB

Keep this medicine out of the sight and reach of children.
Blister: store below 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the carton, blister, and label after Exp. The expiry date refers to the last day of that month.
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 STARAB contains

• The active substance is sodium rabeprazole. Each tablet contains 10 mg (or 20 mg) of sodium rabeprazole.
• Other components are: Tablet core: povidone, mannitol (E421), light magnesium oxide, low-substituted hydroxypropylcellulose, magnesium stearate; Coating: ethylcellulose, light magnesium oxide; Enteric coating: methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, propylene glycol, talc, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).

Description of the appearance of STARAB and contents of the pack
STARAB 10 mg gastro-resistant tablets: biconvex, elliptical, pink, coated tablet.
STARAB 20 mg gastro-resistant tablets: biconvex, elliptical, yellow, coated tablet.
Pack size: 14 and 28 tablets in blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Eberlife Farmaceutici S.p.A.
Via G. Porzio snc
80143 Napoli
Italy

Manufacturer
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria
Special Product’s Line
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy