12.5 mg, 25 mg film-coated tablets
naloxegol
What Moventig is and what it is used for
Moventig contains the active substance naloxegol. It is a drug used in adults to treat constipation caused by painkillers, so-called opioids (eg morphine, oxycodone, fentanyl, tramadol, and codeine ), which are taken regularly. It is used when laxatives have not provided acceptable relief of constipation.
Constipation when using opioids can cause symptoms such as:
- abdominal pain
- difficulty in shaking (you have to shake very hard to get the stool out, which can also cause pain in the anal opening)
- hard stools (stools “hard as stone”)
- insufficient bowel movement (a feeling that there is still stool left in the rectum after bowel movement).
In patients taking opioids, are constipated, and have tried at least one laxative without sufficient relief of constipation, Moventig has been shown in clinical trials to increase the number of bowel movements and relieve constipation symptoms caused by opioids.
What you need to know before taking Moventig
Do not take Moventig:
- if you are allergic to naloxegol or similar medicines, or any of the other ingredients of this medicine (listed in section 6).
- if your intestines are, or may be blocked, or if you have been warned that your intestines may become blocked.
- if you have bowel or peritoneum cancer, advanced stage ovarian cancer or recurrence of the disease, or if you are taking medicines for cancer, such as ‘VEGF inhibitors’ (eg bevacizumab).
- if you are taking certain other medicines such as ketoconazole or itraconazole (for fungal infections), clarithromycin or telithromycin ( antibiotics ) or ritonavir, indinavir or saquvinavir (for HIV ).
Do not take Moventig if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking Moventig.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Moventig:
- if you have a stomach ulcer , Crohn’s disease (a disease that causes the intestine to become inflamed), diverticulitis (another disease with inflammation of the intestine), cancer of the intestine or peritoneum, or any other disease that can damage the intestinal mucosa
- if you are currently having unusually severe, persistent or worsening abdominal pain
- if the natural protective barrier between the blood vessels in the head and in the brain has been damaged, e.g. if you have cancer of the brain or central nervous system , or if you have a central nervous system disease such as multiple sclerosis or Alzheimer’s disease – contact your doctor immediately if your opioid medicines do not relieve pain or if you develop symptoms of opioid withdrawal syndrome (see section 4 )
- if you are taking methadone (see section “Other medicines and Moventig”)
- if you have had a heart attack in the last six months, have heart failure and feel short of breath on a daily basis, or have other severe heart problems with daily symptoms
- if you have kidney problems – your doctor may prescribe another dose (see section “How to take Moventig” below)
- if you have severe liver disease
- if you have pain due to cancer.
Talk to your doctor, pharmacist, or nurse before taking Moventig if any of the above apply to you, or if you are not sure.
Talk to your doctor, pharmacist, or nurse while you are taking Moventig:
- if you get severe, persistent or worsening abdominal pain. This can be a symptom that the intestinal wall has been damaged and can be life-threatening. Tell your doctor immediately. You may need to take a lower dose or stop taking Moventig.
- if you are going to take a break from your opioid medication for more than 24 hours.
- if you experience symptoms of opioid withdrawal syndrome (see section 4 below). Tell your doctor, you may need to stop taking Moventig.
Children and young people
Moventig is not recommended for children and adolescents under 18 years of age as it has not been studied in these age groups.
Other medicines and Moventig
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Tell your doctor what pain-relieving opioids you are taking, and what dose.
Do not take Moventig if you are taking any of the following medicines (see section “Do not take Moventig”):
- ketoconazole or itraconazole – for the treatment of fungal infections
- clarithromycin or telithromycin – antibiotics
- ritonavir, indinavir or saquvinavir – for the treatment of HIV .
Do not take Moventig if any of the above apply to you.
Tell your doctor, pharmacist, or nurse if you are taking any of the following medicines:
- other medicines for constipation (all types of laxatives )
- methadone
- diltiazem or verapamil (for high blood pressure or angina). You may need to take a lower dose of Moventig.
- rifampin (an antibiotic ), carbamazepine (for epilepsy ) or St. John’s wort (a traditional herbal remedy for mild depression). You may need to stop taking Moventig.
- drugs called opioid antagonists (such as naltrexone and naloxone) that are used to counteract the effects of opioids .
Talk to your doctor, pharmacist, or nurse before taking Moventig if any of the above apply to you, or if you are not sure.
Moventig with drink
Do not drink large amounts of grapefruit juice while taking Moventig. Grapefruit juice in large quantities can affect how much naloxegol is absorbed into the body.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine. As there are additional data from the use of this medicine in pregnant women, the use of Moventig during pregnancy is not recommended.
As it is not known if this medicine is excreted in human milk, you should not use Moventig if you are breastfeeding.
Driving and using machines
Moventig is not expected to affect your ability to drive or use any tools or machines.
Moventig contains excipients
This medicine contains less than 1 mmol (23 mg) sodium per 12.5 mg / 25 mg tablet, ie essentially ‘sodium-free’.
How to take Moventig
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one 25 mg tablet daily.
Take Moventig in the morning, so you do not have to go to the toilet in the middle of the night. Moventig should be taken on an empty stomach, at least 30 minutes before the first meal of the day or 2 hours after the first meal of the day.
When you start with Moventig, you should stop taking all other laxatives until your doctor tells you to start using them again.
Your doctor may decide that you should take a lower dose of 12.5 mg
- if you have kidney problems
- if you are taking diltiazem or verapamil (for high blood pressure or angina).
Your doctor may increase your dose to 25 mg, depending on how you react to the treatment.
If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you can crush it and mix it with water as follows:
- Crush the tablet to a powder
- Pour the powder into half a glass of water (120 ml)
- Stir and drink immediately
- To make sure there is no medicine left, rinse the empty glass with another half glass of water (120 ml) and drink it.
If you take more Moventig than you should
If you take more Moventig than you should, talk to a doctor or go to the hospital.
If you forget to take Moventig
- If you miss a dose of Moventig, take it as soon as you remember. However, if there are less than 12 hours left before it is time for the next dose , skip the missed dose .
- Do not take a double dose to make up for a forgotten dose .
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and contact a doctor immediately if you develop opioid withdrawal symptoms (when you have a combination of three or more of the following symptoms: depression, nausea, vomiting, muscle aches, increased tear flow, runny nose, dilated pupils, goosebumps, heavy sweating, diarrhea), yawning, fever or difficulty sleeping), which usually occurs within the first few days after starting treatment with naloxegol. Opioid withdrawal symptoms can occur in up to 1 in 100 people.
Other possible side effects:
Very common (may affect more than 1 in 10 people):
- abdominal pain
- diarrhea (frequent and watering stools)
Common (may affect up to 1 in 10 people):
- intestinal gases
- nausea
- vomiting
- nasopharyngitis (runny or stuffy nose)
- headache
- heavy sweating
Has been reported (occurs in an unknown number of users):
- allergic reaction
- development of holes in the intestinal wall ( gastrointestinal perforation )
Reporting of side effects ar
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
How to store Moventig
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 after “EXP”. The expiration date is the last day of the specified month.
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.
Contents of the pack and other information
Content declaration
- The active substance is naloxegol.
- Each Moventig 12.5 mg film-coated tablet (tablet) contains 12.5 mg of naloxegol in the form of naloxegol oxalate.
- Each Moventig 25 mg film-coated tablet (tablet) contains 25 mg of naloxegol in the form of naloxegol oxalate.
- Other ingredients are:
- tablet core: mannitol (E421), microcrystalline cellulose (E460), croscarmellose sodium (E468) – see section 2 under “Moventig contains sodium”, magnesium stearate (E470b), propyl gallate (E310).
- film coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), red iron oxide (E172) and black iron oxide (E172).
What the medicine looks like and contents of the pack
Moventig 12.5 mg: pink, oval film-coated tablet measuring 10.5 x 5.5 mm, marked with “nGL” on one side and “12.5” on the other side.
Moventig 25 mg: pink, oval film-coated tablet measuring 13 x 7 mm, marked with “nGL” on one side and “25” on the other side.
Moventig 12.5 mg tablets are available in aluminum blisters in pack sizes of 30 or 90 film-coated tablets in blister packs without perforation and as 30 x 1 or 90 x 1 film-coated tablet in perforated unit dose blisters.
Moventig 25 mg tablets are available in aluminum blisters in pack sizes of 10, 30, or 90 film-coated tablets in blister packs without perforation, and as 10 x 1, 30 x 1, 90 x 1, or 100 x 1 film-coated tablet in perforated unit dose blisters.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder
Kyowa Kirin Holdings BV
Bloemlaan 2
2132NP Hoofddorp
Netherlands
Manufacturer
Piramal Healthcare UK Limited
Whalton Road
Morpeth
Northumberland, NE61 3YA
UK