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DIOTOP 75 MG / 20 MG MODIFIED-RELEASE HARD CAPSULES

Active substance(s): DICLOFENAC SODIUM / OMEPRAZOLE / DICLOFENAC SODIUM / OMEPRAZOLE

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Package Leaflet: Information for the User
Diotop 75 mg / 20 mg modified-release hard capsules
diclofenac sodium/omeprazole
For use in adults

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, please ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

What is in this leaflet
1.
What Diotop 75 mg / 20 mg modified-release hard capsules is and what it is used for
2.
What you need to know before you take Diotop 75 mg / 20 mg modified-release hard capsules
3.
How to take Diotop 75 mg / 20 mg modified-release hard capsules
4.
Possible side effects
5.
How to store Diotop 75 mg / 20 mg modified-release hard capsules
6.
Contents of the pack and other information

1. What Diotop 75 mg / 20 mg modified-release hard capsules is and what it is used for
Diotop 75 mg / 20 mg modified-release hard capsules contains two active ingredients in a single capsule.
These active ingredients are diclofenac sodium (75 mg) and omeprazole (20 mg). Diotop 75 mg / 20 mg
modified-release hard capsules is indicated in adults that are adequately controlled with diclofenac and
omeprazole.
Diclofenac is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and is
used to reduce pain and inflammation of joint disorders.
Omeprazole belongs to a group of medicines called ‘proton pump inhibitors’ which reduce the amount of
acid that your stomach produces. Omeprazole reduces the risk of developing peptic ulcers (ulcers in your
stomach or duodenum) caused by non-steroidal anti-inflammatory drugs (NSAIDs).
Diotop 75 mg / 20 mg modified-release hard capsules has been prescribed for you because you have
symptoms caused by a joint disorder such as osteoarthritis, rheumatoid arthritis or ankylosing spondylitis.
In addition, you may be at risk of developing peptic ulcers when taking (NSAIDs).

2. What you need to know before you take Diotop 75 mg / 20 mg modified-release hard capsules
Do not take the capsules






if you are allergic to diclofenac, omeprazole or any of the other ingredients of this medicine (listed in
section 6).
if you have had an allergic reaction to ibuprofen, acetylsalicylic acid or other NSAIDs.
if you are allergic to medicines containing other proton pump inhibitors (eg pantoprazole,
lansoprazole, rabeprazole, esomeprazole).
if you have severe liver, kidney or heart failure
if you are in the last three months of pregnancy
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if you are taking a medicine containing nelfinavir (used for HIV infection)
if you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer or bowel
perforation
if you have now, or have even had, bleeding in the digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces)
if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart
attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation
to clear or bypass blockages
if you have or have had problems with your blood circulation (peripheral arterial disease)

Make sure your doctor knows, before you are given diclofenac

If you smoke

If you have diabetes

If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
If you think any of these apply to you, or you are unsure, do not take the capsules. Talk to your doctor first
and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Diotop 75 mg / 20 mg modified-release hard capsules if
you are also taking other NSAIDs. Diotop 75 mg / 20 mg modified-release hard capsules should not be
used at the same time as other NSAIDs.
Diotop 75 mg / 20 mg modified-release hard capsules may hide the symptoms of other diseases or make
them worse. Therefore, if any of the following happen to you before you start taking Diotop 75 mg / 20 mg
modified-release hard capsules or while you are taking it, talk to your doctor straight away:












You have asthma, hayfever or other allergies, polyps in your nose, difficulty breathing (COPD), long
term respiratory infections.
You suffer from Crohn's disease or ulcerative colitis.
You have SLE (Systemic Lupus Erythematosus), an inflammation of the connective tissue.
You have heart, kidney or liver problems (your doctor may want to carry out some tests while you
are taking the capsules).
You have high blood pressure.
You have blood clotting problems.
You lose a lot of weight for no reason or have problems swallowing.
You get stomach pain or indigestion.
You begin to vomit food or blood.
You pass black stools (blood-stained faeces).
You experience severe or persistent diarrhoea, as omeprazole has been associated with a small
increase in infectious diarrhoea.

Tell your doctor if you are about to have major surgery.
Because Diotop 75 mg / 20 mg modified-release hard capsules contains a NSAID, it can make the
symptoms of an infection (such as fever, pain) less noticeable.
Medicines such as Diotop 75 mg / 20 mg modified-release hard capsules may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and
prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, previously had a stroke or think that you might be at risk of these conditions
(for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should
discuss your treatment with your doctor or pharmacist.
If you take Diotop 75 mg / 20 mg modified-release hard capsules on a long-term basis (longer than 1 year)
your doctor will probably keep you under regular surveillance. You should report any new and exceptional
symptoms and circumstances whenever you see your doctor.
Taking a proton pump inhibitor like Diotop 75 mg / 20 mg modified-release hard capsules, especially over
a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell
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your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of
osteoporosis).
Other medicines and Diotop 75 mg / 20 mg modified-release hard capsules
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. This is because Diotop 75 mg / 20 mg modifiedrelease hard capsules can affect the way some medicines work and some medicines can have an effect
on Diotop 75 mg / 20 mg modified-release hard capsules.
Do not take Diotop 75 mg / 20 mg modified-release hard capsules if you are taking a medicine containing
nelfinavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:

Other painkillers or anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, or any other
medicines used to prevent platelet clumping

Medicines to lower blood pressure (anti-hypertensives)

Anti-diabetic tablets

Certain antibiotics, such as ciprofloxacin

Ciclosporin or tacrolimus (immunosuppressive medicines, used to dampen down the body's immune
reactions)

Corticosteroids

Mifepristone (for early termination of pregnancy)

Heart drugs, such as digoxin

Medicines used to treat heart conditions or high blood pressure, for example betablockers or ACE
inhibitors.

Diuretics ("water tablets"), including the potassium-sparing type

Lithium (a medicine used to treat mood swings and some types of depression)

Selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat some types of depression)

Methotrexate (a medicine used to treat arthritis and some types of cancer)

Zidovudine (used to treat HIV infection)

Colestipol or cholestyramine (medicines used to lower cholesterol levels)

Sulfinpyrazone (used to treat gout)

Diazepam (used to treat anxiety, relax muscles or in epilepsy)

Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when
you start or stop taking Diotop 75 mg / 20 mg modified-release hard capsules

Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor
may need to monitor you when you start or stop taking Diotop 75 g / 20 mg modified-release hard
capsules

Rifampicin (used to treat tuberculosis)

Atazanavir (used to treat HIV infection)

St John’s wort (Hypericum perforatum) (used to treat mild depression)

Cilostazol (used to treat transient pain or fatigue in the muscles of the lower leg)

Saquinavir (used to treat HIV infection)

Clopidogrel (used to prevent blood clots (thrombi))

Erlotinib (used to treat cancer)

Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a
fungus)

Clarithromycin (a medicine used to treat bacterial infections)

Children
These capsules are not suitable for children.
Elderly patients
If you are elderly, your doctor may want to monitor you carefully while you are taking Diotop 75 mg / 20
mg modified-release hard capsules.
Pregnancy, breast feeding and fertility
Tell your doctor before taking Diotop 75 mg / 20 mg modified-release hard capsules if you are pregnant or
breast feeding. As with other non-steroidal anti-inflammatory drugs, Diotop 75 mg / 20 mg modified3

release hard capsules may make it more difficult to become pregnant. You should inform your doctor if
you are planning to become pregnant or if you have problems becoming pregnant.
Diotop 75 mg / 20 mg modified-release hard capsules must not be taken during the last three months of
pregnancy (see “Do not take the capsules” above). It is not usually recommended at other stages of
pregnancy, but you may be able to take it if your doctor advises that it is necessary for you.
Diotop 75 mg / 20 mg modified-release hard capsules should be avoided if you are breast feeding, as
small amounts of the medicine may pass into breast milk.
Driving and using machines
These capsules can cause some people to feel dizzy or giddy, drowsy or sleepy, tired or have problems
with their vision. If you are affected, do NOT drive or operate machinery.

3. How to take Diotop 75 mg / 20 mg modified-release hard capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is one capsule of Diotop 75 mg / 20 mg modified-release hard capsules daily. If
your symptoms are not controlled by a once daily dosing, please talk to your doctor. Never take more than
one capsule of Diotop 75 mg / 20 mg modified-release hard capsules per day as this could increase the
risk of side-effects.
Diotop 75 mg / 20 mg modified-release hard capsules are intended for oral use. The capsules must be
swallowed whole with a drink of water (about half a glass). Do not chew or break open Diotop 75 mg
modified-release hard capsules. The capsules are best taken with or after food. It may help you to
remember to take your capsules if you take them at the same time every day, perhaps with breakfast or
an evening meal.
If you take more Diotop 75 mg / 20 mg modified-release hard capsules than you should
If you take more capsules than you should or if a child accidentally swallows some, go to your doctor or
nearest emergency department immediately and take your medicine pack with you.
If you forget to take Diotop 75 mg / 20 mg modified-release hard capsules
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Taking this
medicine for the shortest possible time will minimise side effects.
Some side effects can be serious. Stop taking Diotop 75 mg / 20 mg modified-release hard capsules and
tell your doctor immediately if you notice any of the following symptoms:
Symptoms caused by Diclofenac

Passing blood in your faeces (stools/motions)






Bleeding from the stomach or intestines (e.g. passing black „tarry‟ stools)
Vomiting blood or dark particles that look like coffee grounds
Stomach pains or other abnormal stomach symptoms
Indigestion or heartburn
Allergic reactions, which can include sudden wheeziness, difficulty in breathing, swelling of the face,
lips, hand or fingers, skin rash, itching, bruising, painful red areas, peeling or blistering.

Symptoms caused by Omeprazole

Sudden wheezing, swelling of your kips, tongue and throat or body, rash, fainting or difficulties in
swallowing (severe allergic reaction).

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Reddening of the skin with painful red areas, blisters or peeling. There may also be severe blisters
and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’
or ‘toxic epidermal necrolysis’.
Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

Your doctor may require you to have occasional check-ups while you are taking Diotop 75 mg / 20 mg
modified-release hard capsules.
Other side effects caused by Diclofenac include:
Common side effects (may affect more than 1 in 10 people):

Headache, dizziness and giddiness.

Sickness, feeling sick, flatulence, diarrhoea, loss of appetite.

Stomach pains or other abnormal stomach symptoms, indigestion or heartburn.

Changes in blood tests that check how the liver is working.

Rash.
Rare side effects (may affect up to 1 in 1,000 people):

Allergic reactions, including sudden wheeziness, difficulty in breathing, swelling of the face, lips,
tongue, hands or fingers, skin rash, itching, bruising, painful red areas, peeling or blistering.
Problems swallowing.

Tiredness, sleepiness.

Blood in your faeces, bleeding from the stomach or intestines (e.g. passing black „tarry‟ stools).

Vomiting blood or dark particles that look like coffee grounds.

Stomach ulcer or duodenal ulcer.

Liver problems, jaundice (yellowing of the skin or whites of the eyes).

Rashes and spots (urticaria).

Perforation of the stomach or bowel (gastrointestinal perforation).
Very rare side effects (may affect up to 1 in 10,000 people):

Anaemia.

Depression, disorientation, insomnia, irritability, mood changes, nightmares.

Memory problems, pins and needles.

Stiff neck which could be a sign of meningitis.

Confusion, hallucinations, feeling unwell.

Changes in taste, tremor, fits, anxiety.

Blurred vision, double vision.

Impaired hearing, tinnitus (ringing in the ears).

Worsening of Crohn´s disease or of ulcerative colitis.

Constipation (including blockages).

Oesophageal disorders.

Inflammation of the pancreas.

Sensitivity to light, skin rashes, blisters on the skin and sore mouth/eyes, flaky skin, eczema and
unusual bruising, hair loss.

Kidney problems, urinary problems (e.g. change in the usual amount or colour of the urine).

Decrease in the number of white blood cells (leucopenia)

Inflammation of the lung tissue (pneumonitis)
Other effects:
Diclofenac may be associated with a small increased risk of heart attack (“myocardial infarction”) or
stroke.
Other side effects reported in association with non-steroidal anti-inflammatory drugs include swelling
caused by a build-up of fluid (known as oedema), high blood pressure, palpitations, chest pain and heart
failure.

Other side effects caused by Omeprazole include:

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

Headache.

Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).

Feeling sick (nausea) or being sick (vomiting).
Uncommon side effects (may affect up to 1 in 100 people):

Swelling of the feet and ankles.

Disturbed sleep (insomnia).

Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.

Spinning feeling (vertigo).

Skin rash, lumpy rash (hives) and itchy skin.

Generally feeling unwell and lacking energy.

Abnormal liver blood tests.

Fracture of hip, wrist or spine.

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

Blood problems such as a reduced number of white cells or platelets. This can cause weakness,
bruising or make infections more likely.

Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever,
wheezing.

Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.

Feeling agitated, confused or depressed.

Taste changes.

Eyesight problems such as blurred vision.

Suddenly feeling wheezy or short of breath (bronchospasm).

Dry mouth.

An inflammation of the inside of the mouth.

An infection called “thrush” which can affect the gut and is caused by a fungus.

Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.

Hair loss (alopecia).

Skin rash on exposure to sunshine.

Joint pains (arthralgia) or muscle pains (myalgia).

Severe kidney problems (interstitial nephritis).

Increased sweating.
Very rare side effects (may affect up to 1 in 10,000 people):

Changes in blood count including agranulocytosis (lack of white blood cells).

Aggression.

Seeing, feeling or hearing things that are not there (hallucinations).

Severe liver problems leading to liver failure and inflammation of the brain.

Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high
fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal
necrolysis).

Muscle weakness.

Enlarged breasts in men.
Not known (frequency cannot be estimated from the available data)
 Inflammation in the gut (leading to diarrhoea).
 If you are on Diotop 75 mg / 20 mg modified-release hard capsules for more than three months it is
possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen
as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart
rate. If you get any of these symptoms, please tell your doctor 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 monitor your levels of magnesium.

Other effects:

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Omeprazole may in very rare cases affect the white blood cells leading to immune deficiency. If you have
an infection with symptoms such as fever with a severely reduced general condition or fever with
symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must
consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled
out by a blood test. It is important for you to give information about your medicine at this time.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Diotop 75 mg / 20 mg modified-release hard capsules
Keep this medicine out of the sight and reach of children.
Do not use the medicine after the expiry date which is stated on the carton and on the blister strip. The
expiry date refers to the last day of that month.
HDPE Bottle/Blister: Do not store above 30 °C.
HDPE Bottle:
Shelf life after first opening: 1 month
Store in the original package. Keep the bottle tightly closed in order to protect from moisture.
Blister:
Store this blister in the original package in order to protect from moisture.
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 to protect the environment.

6. Contents of the pack and other information
What Diotop 75 mg / 20 mg modified-release hard capsules contains
The active substances are diclofenac sodium and omeprazole.
Each modified-release capsule, hard contains 75 mg diclofenac sodium and 20 mg omeprazole.
The other ingredients are:
Capsules content:
Microcrystalline cellulose, Povidone K 25, Colloidal anhydrous silica, Methacrylic acid ethyl acrylate
copolymer (1:1), Type A, neutralized with (6 mol%) sodium hydroxide, Propylene glycol, Ammonio
methacrylate copolymer type A, Ammonio methacrylate copolymer type B, Mannitol, Magnesium
carbonate heavy, Hydroxypropylcellulose (75-150 mPas/5% sol.), Sodium laurilsulfate, Hypromellose
(6mPas), Methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30% (dry substance), Polysorbate 80
Triethyl citrate, Talc,
Capsules shell:
Titanium dioxide (E171), Iron oxide red E 172, Iron oxide yellow E 172, Gelatin

What Diotop 75 mg / 20 mg modified-release hard capsules looks like and contents of the pack
Diotop 75 mg / 20 mg modified-release hard capsules are elongated hard gelatin capsules with pink
opaque cap and yellow opaque body, filled with white to light yellow pellets.
Pack sizes
HDPE bottles: 30 modified-release hard capsules
Blister: 10, 20, 30, 50, 60, 100 modified-release hard capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
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Temmler Pharma GmbH & Co. KG
Temmlerstrasse 2
35039 Marburg
Germany
Manufacturer
C.P.M. ContractPharma GmbH & Co. KG
Frühlingstr. 7
D-83620 Feldkirchen-Westerham
Germany

Haupt Pharma Amareg GmbH
Donaustaufer Straße 378
93055 Regensburg
Germany

This medicinal product is authorised in the Member States of the EEA under the following names:
Austria
Estonia
Latvia
Lithuania
Malta
United Kingdom

Diotop 75 mg / 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Diotop
Diotop 75 mg / 20 mg modificētās darbības cietās kapsulas
Diotop 75 mg / 20 mg modifikuoto atpalaidavimo kietosios kapsulės
Diotop 75 mg / 20 mg kapsula li terħi il‐mediċina b'mod modifikat, iebsa
Diotop 75 mg / 20 mg modified release hard capsules

This leaflet was last revised in November 2016.

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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