STARAB 10 mg Enteric-Coated Tablet

Содержание инструкции

1. STARAB 10 mg gastro-resistant tablets, 20 mg gastro-resistant tablets
   1. What is STARAB 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

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

rabeprazole
Generic medicine

Read this leaflet carefully before taking 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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is STARAB 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 by the stomach.
STARAB is used to treat:

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

In combination with two antibiotics (clarithromycin and amoxicillin) STARAB is used for
the eradication of H. pyloriinfection in patients with peptic ulcer. For further
information on the antibiotics used in H. pylorieradication therapy, see their respective
package leaflets.

2. What you need to know before taking STARAB

Do not take STARAB

• If you are allergic to rabeprazole sodium or 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 substitutes”.
• If you have or have had any problems with your liver.
• If you have problems with your liver or blood; such problems have occurred in some patients and resolved with discontinuation of treatment with STARAB.
• If you have been diagnosed with a stomach tumor.
• If you have reduced body stores or risk factors that reduce the absorption of vitamin B12 and are receiving long-term treatment with rabeprazole sodium. Like all other acid-reducing agents, rabeprazole sodium can 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 stomach acid.
• If you are going to undergo a specific blood test (Chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact
your doctor as soon as possible, as it may be necessary to stop therapy with
STARAB. Remember to also report any other undesirable effects such as joint pain.
If these conditions apply to you, talk to your doctor before taking STARAB.
If you have severe diarrhea (watery or with blood) with symptoms such as fever, pain or
abdominal tenderness, stop taking STARAB and contact your doctor.
The doctor may perform or have performed another examination called an endoscopy to diagnose
your condition and/or rule out malignancy. The possibility of stomach and
esophageal tumors must be excluded before starting treatment.
If you take STARAB for a long time (over 1 year), your doctor will probably
subject you to periodic monitoring. When you see your doctor, you should report all new
or different symptoms you have noticed.
If you are taking a proton pump inhibitor such as STARAB, especially for a period
longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or
spine. If you suffer from osteoporosis or are taking corticosteroids (which can
increase the risk of osteoporosis) consult your doctor.
During treatment with STARAB, some abnormal blood values have been reported. In
general, the values return to normal when treatment is stopped.
During the intake of rabeprazole, an inflammation of the kidneys can occur. Signs and symptoms
may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should report these signs to
your treating physician.

Children
The use of STARAB is not recommended in children.

Other medicines and STARAB
Tell 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); it is not recommended to take STARAB if you are taking atazanavir.
• Ketoconazole or itraconazole (used to treat fungal infections).
• Methotrexate (a chemotherapeutic medicine used at high doses to treat tumors) - if you are taking a high dose of methotrexate, your doctor may temporarily interrupt your treatment with STARAB.

Pregnancy and breastfeeding
STARAB should not be used during pregnancy or breastfeeding.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, 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 can occasionally cause drowsiness. Therefore, if you feel
drowsy, you should avoid driving or using 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 following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Adults and the elderly

Duodenal ulcers and benign gastric ulcers:20 mg of STARAB to be taken once a day
in the morning. Most patients suffering from duodenal ulcer are treated for
four weeks and most patients with a benign stomach ulcer are
treated for six weeks. However, some patients may require further treatment to
achieve healing.

Gastroesophageal reflux disease (GERD) with ulcer:20 mg of STARAB to be taken once a
day for four to eight weeks.

Long-term treatment of gastroesophageal reflux disease (GERD): 10 mg or 20 mg
of STARAB once a day depending on the response.

Symptomatic treatment of gastroesophageal reflux disease:10 mg of STARAB once a
day for 4 weeks. Once the symptoms have disappeared, your doctor may tell you to take 10 mg of
STARAB once a day as needed for subsequent symptom control.

Zollinger-Ellison syndrome:60 mg of STARAB once a day to start. The dose may
then be adjusted by your doctor depending on the response to treatment. Your doctor will
tell you how many tablets to take and when.

Eradication of H. pylori:20 mg of STARAB to be taken twice a day, usually for
7 days (in combination with two antibiotics: clarithromycin and amoxicillin).

Patients with liver problems
You should consult your doctor who will pay particular attention at the beginning of your treatment
with STARAB and throughout the therapy.

Use in children
STARAB is not recommended 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 a day, 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 a missed dose. If you forget to
take a dose, take it as soon as you remember. If it is almost time to take the next dose,
wait until then.

4. Possible side effects

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

Stop taking 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 may cause fainting or collapse.
• Frequent infections such as sore throat or fever or mouth ulcers or sore throat.
• Bruising or bleeding that occurs easily. These side effects are rare (they occur in less than 1 in 1,000 people).
• Severe blistering skin reactions or irritation or ulcers in the mouth and throat. These side effects are very rare (they occur in less than 1 in 10,000 people).

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

• cough, sore throat (pharyngitis), runny nose, common cold
• nausea, vomiting, abdominal pain, diarrhoea, constipation, flatulence (gas)
• back pain, non-specific pain
• weakness or loss of strength, flu-like symptoms
• difficulty falling asleep
• headache, dizziness
• infection
• benign polyps in the stomach.

Not common (may affect up to 1 in 100 people):

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

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

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

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

• sudden onset of severe skin rash or formation of blisters or peeling of the skin. It 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 can lead to fatigue, confusion, muscle spasms, convulsions 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 levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in blood levels of potassium or calcium. The doctor should decide whether to periodically check magnesium levels in the blood.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through 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 at a temperature below 25°C. Store in the original package to
protect the medicine from humidity.
Do not use this medicine after the expiry date which is stated on the carton, on the blister and
on the label after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What STARAB contains

• The active ingredient is rabeprazole sodium. Each tablet contains 10 mg (or 20 mg) of rabeprazole sodium.
• The other ingredients 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: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