PANTOPRAZOLE 20 mg GASTRO-RESISTANT TABLETS

Pantoprazole (as pantoprazole sodium sesquihydrate)

Read all of this leaflet carefully before you start

taking this medicine.

♦    Keep this leaflet. You may need to read it again.

♦    If you have any further questions, ask your doctor or pharmacist.

♦    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if theirsymptoms are the same as yours.

♦    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctoror pharmacist.

1.    What Pantoprazole Tablets are and what they are used for

2.    Before you take Pantoprazole Tablets

3.    How to take Pantoprazole Tablets

4.    Possible side effects

5.    How to store Pantoprazole Tablets

6.    Further information

OWHAT PANTOPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR

PantoprazoleTablets are a selective "proton pump inhibitor','a medicine which reduces the amount of acid produced byyour stomach. It is used for treating acid-related diseases of the stomach and intestine.

Pantoprazole Tablets are used for:

Adults and adolescents 12 years of age and above:

♦ Treating symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro-oesophageal reflux disease caused by reflux of acid from the stomach ♦ Long-term management of reflux oesophagitis (inflammation of the oesophagus accompanied by the regurgitation of stomach acid) and preventing its return.

Adults:

♦ Preventing duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at riskwho need to take NSAIDs continuously.

BEFORE YOU TAKE PANTOPRAZOLE TABLETS Do not take Pantoprazole Tablets

• If you are allergic (hypersensitive) to pantoprazole orto any of the otheringredients of PantoprazoleTablets (section 6)

♦ Ifyou are allergic to medicines containing other proton pump inhibitors.

Take special care with Pantoprazole Tablets ♦ Ifyouhavesevereliverproblems. Please tell your doctorifyou have ever had problems with yourliver. Hewill checkyour liverenzymes more frequently, especiallywhen you are taking PantoprazoleTablets as a long-term treatment.

In the case of a rise of liver enzymes the treatment should be stopped.

• If you need to take medicines called NSAIDs continuouslyand receive PantoprazoleTablets because you have an increased risk of developing stomach and intestinal complications. Anyincreased risk will be assessed according to your own personal risk factors such as yourage (65 years old or more), a history of stomach or duodenal ulcers orof stomach or Intestinal bleeding.

♦ If you have reduced body stores or risk factors for reduced vitamin B12 and receive pantoprazole long-term treatment. Aswith all acid reducing agents, pantoprazole may lead to a reduced absorption ofvitamin B12.

• Ifyou are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same timeas pantoprazole, askyour doctor for specific advice.

Taking a proton pump inhibitor like Pantoprazole Tablets, especially overa period of more than one year, may slightlyincrease your risk offracture in the hip, wrist or spine. Tell your doctor ifyou have osteoporosis orifyouare taking corticosteroids (which can increase the risk of osteoporosis).

Tell your doctor immediately if you notice any of the following symptoms:

♦    anunintentionallossofweight

♦    repeatedvomiting

♦    difficultyinswallowing

♦    vomiting blood

♦    you look pale and feel weak (anaemia)

♦    you notice blood inyour stools

♦    severe and/orpersistent diarrhoea, as PantoprazoleTablets have been associated with a small increase in infectious diarrhoea.

Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause delayin diagnosing it. Ifyour symptoms continue in spite of your treatment, further investigations will be considered.

Ifyou take PantoprazoleTablets on a long-term basis (longer than 1 year) yourdoctor will probably keep you under regular surveillance.

You should report any new and exceptional symptoms and circumstances wheneveryou see your doctor.

Taking other medicines PantoprazoleTablets mayinfluence the effectiveness of othermedicines, so tell your doctor ifyou are taking

♦    Medicines such as ketoconazole, itraconazole and posaconazole (used to treatfungal infections) orerlotinib (used for certain types of cancer) because PantoprazoleTablets may stop these and other medicines from working properly

♦    Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks.

♦    Atazanavir(used to treat HIV-infection).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding

There are no adequate data from the use of pantoprazole in pregnantwomen. Excretion into human milk has been reported. If you are pregnant, orthinkyou may be pregnant, or ifyou are breast-feeding, you should use this medicine only ifyour doctor considers the benefit foryou are greater than the potential risk foryour unborn child or baby.

Askyour doctor orpharmacistfor advice before taking any medicine.

Driving and using machines

Ifyou experience side effects like dizziness or disturbed vision, you should not drive or operate machines.

Important information about some of the ingredients of Pantoprazole Tablets

This product contains 2.93 mg of sodium per tablet. You should take this into account ifyou are on a controlled sodium diet.

Q HOW TO TAKE PANTOPRAZOLE TABLETS

Always take PantoprazoleTablets exactly as your doctor has told you.You should checkwith your doctor or pharmacist if you are not sure.

When and how should you take Pantoprazole Tablets ?

Take the tablets 1 hour before a meal without chewing orbreaking them and swallow them whole with some water.

Unless told otherwise by yourdoctor, the usual dose is:

Adults and adolescents 12 years of age and above:

To treat symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro-oesophageal reflux disease

The usual dose is one tablet a day. This dose usuallybrings relief within 2 -4weeks -atmost afteranother 4weeks.Your doctorwill tell you how long to continue taking the medicine. After this any recurring symptoms can be controlled by taking one tablet daily, when required.

For long-term management and for preventing the return of reflux oesophagitis The usual dose is one tablet a day. If the illness returns, your doctor can double the dose, inwhich case you can use Pantoprazole 40 mgTablets instead, one a day. After healing, you can reduce the dose back again to one tablet 20 mg a day. Adults:

To prevent duodenal and stomach ulcers in patients who need to take NSAIDs continuously

The usual dose is one tablet a day.

Special patient groups:

♦    If you sufferfrom severe liverproblems, you should not take more than one 20 mg tablet a day

♦    Childrenbelow 12years. These tablets are not recommended for useinchildren below 12years.

If you take more Pantoprazole Tablets than you should

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

If you forget to take Pantoprazole Tablets

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

If you stop taking Pantoprazole Tablets

Do not stop taking these tablets withoutfirst talking to your doctor or pharmacist.

If you have any further questions about the use of this product, askyour doctoror pharmacist.

Q POSSIBLE SIDE EFFECTS

Like all medicines, Pantoprazole tablets can cause side effects, although not everybody gets them. The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 userin 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 userin 10,000) not known (frequency cannot be estimated from the available data).

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

♦    Serious allergic reactions (frequency rare): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quincke's oedema/angioedema), severe dizziness with veryfast heartbeat and heavy sweating.

♦    Serious skin conditions (frequency not known): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and sensitivity to light.

♦    Other serious conditions (frequency not known):

yellowing of the skin orwhites of the eyes (severe damage to liver cells, jaundice) orfever, rash, and enlarged kidneys sometimes with painful urination and lower back pain (serious inflammation of the kidneys).

Other side effects are:

♦    Uncommon (affects 1 to 10 users in 1,000) headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disorders, fracture of the hip, wrist or spine.

♦    Rare (affects 1 to 10 users in 10,000) disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight

changes; raised body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.

♦    Very Rare (affects less than 1 userin 10,000) disorientation.

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

Hallucination, confusion (especiallyin patients with a history of these symptoms); decreased sodium level in blood.

If you are on PantoprazoleTablets for more than three months it is possible that the levels of magnesium inyour blood mayfall. Lowlevels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. Ifyou get any of these symptoms, please tell yourdoctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitoryour levels of magnesium. Side effects identified through blood tests:

♦    Uncommon (affects 1 to 10 users in 1,000) an increase in liver enzymes.

♦    Rare (affects 1 to 10 users in 10,000)

an increase in bilirubin; increased fats in the blood.

♦    Very Rare (affects less than 1 userin 10,000) a reduction in the number of blood platelets, which may cause you to bleed orbruise more than normal; a reduction in the number of white blood cells, which may lead to more frequentinfections.

If any of the side effects become serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

(5 HOW TO STORE PANTOPRAZOLE TABLETS

Keep out of the reach and sight of children.

Store below 30°C.

Do not use PantoprazoleTablets after the expiry date which is stated on the pack after EXP The expirydate refers to the last day of that month. Medicines should notbe disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.

Q FURTHER INFORMATION

What Pantoprazole Tablets contain

♦    The active substance is Pantoprazole. Each gastro-resistant tablet contains, 20 mg Pantoprazole (as pantoprazole sodium sesquihydrate).

♦    Theotheringredientsare:

Core: Disodium Phosphate Anhydrous, Mannitol (E421), Cellulose Microcrystalline, Croscarmellose Sodium, Magnesium Stearate (vegetable) Coating: Hypromellose,Triethyl Citrate, Sodium Starch Glycolate (Type A), Methacrylic acid-Ethyl acrylate copolymer,Yellow Iron Oxide (E172). What Pantoprazole Tablets look like and contents of the pack

Pantoprazole 20 mg gastro-resistant tablets are oval,yellow tablets.

Packs: bottles (HDPE containers with child resistant closure) and blister (aluminium/ aluminium blister).

Pantoprazole Tablets are available in the following pack sizes: Packs with 7,14, 15, 28,30, 56, 60, 98 and 100 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

TEVA UK Limited, Brampton Road, Hampden Park,

East Sussex, BN22 9AG, United Kingdom.

Manufacturer

Teva Pharma S.L.U., Poligono Industrial Malpica, calle C, Numero 4, 50016, Zaragoza, Spain.

This leaflet was last approved in October 2013

PL00289/1496

88146-D

F. P. Code:

EAN Code: Pharma Code: Edge Code: Third party code: Fonts:

Base Font Size:

231-10-01210

N/A

N/A

N/A

N/A

Univers 8.75 Pt

Dimensions:

L:

W:

D:

Foil Width: Perforated:

320 mm 170 mm mm

N/A

N/A

Colours:

(PANTONE® is a registered trademark of Pantone, Inc.)

PANTONE® GREEN C PANTONE® BLACK C

Artwork Originator; Sign & Date:

Clvzafjuv I

Digitally signed by Elizabeth Morgan DN: cn=Elizabeth Morgan, o=Teva UK Ltd, ou=Origination Dept, email=elizabeth.morga n@tevauk.com, c=GB Date: 2013.11.04 15:06:42 Z

Artwork Checker;    Digitally signed by

^Sign & ^Date:    Simon Wilkinson

DN: cn=Simon Wilkinson, o=Teva UK Ltd, ou=Artwork Origination, email=SWilkinson@tev auk.com, c=GB Date: 2013.11.04 16:24:26 Z

Approved for Regulatory submission into MHRA/IMB; Sign & Date:

Poonam

Shelar

Digitally signed by Poonam Shelar DN: cn=Poonam Shelar, o, ou=Teva UK Ltd Harlow, email=poonam. shelar@tevauk.com, c=GB Date: 2013.11.04 16:58:50

Z

Final approval by MA Holder confirming receipt of MHRA/IMB approval; Sign & Date:

Packing Site Approval (where not TEVA UK Limited) Sign & Date:

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier. We must receive a copy of any 3rd Party Supplier’s Proof before approval to print willbe granted.