film-coated tablets 
Extracts of pollen from rye, timothy, and maize

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • 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. See section 4.
  • You should talk to a doctor if you do not feel better or if you feel worse within 6 months.

In this leaflet you will find information about: 
1. What Cernitol Novum is and what it is used for 
2. What you need to know before you use Cernitol Novum 
3. How to use Cernitol Novum 
4. Possible side effects 
5. How to store Cernitol Novum 
6. Contents of the pack and other information 

What Cernitol Novum is and what it is used for

Cernitol Novum is herbal medicine for the treatment of symptoms of benign prostatic hyperplasia, e.g. frequent urination and nocturnal urination.

What you need to know before you use Cernitol Novum

Do not use Cernitol Novum

  • if you are allergic (hypersensitive) to rye, timothy, or maize pollen extracts or to any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

  • Talk to your doctor before taking Cernitol Novum to rule out an underlying, serious illness ( prostate or bladder cancer).
  • If the symptoms worsen or persist for more than 6 months, you should contact a doctor to have a new assessment made. Also, consult a doctor if new symptoms should occur.
  • If you need to have a blood test called “PSA”, it is important that you tell your doctor or nurse that you are using Cernitol Novum, as the results of this test may be affected.

Children and young people

There is no use of Cernitol Novum in children and adolescents.

Other medicines and Cernitol Novum

When in contact with a doctor or other healthcare professional, remember to tell them that you are taking or have recently taken this over-the-counter medicine.

Cernitol Novum with food, drink, and alcohol

The possible effects of consuming food, drink, or alcohol with Cernitol Novum have not been studied.

Pregnancy, breastfeeding, and fertility

There is no use of Cernitol Novum in women.

The potential effect of the drug on male fertility has not been studied.

Driving and using machines

Cernitol Novum has no or negligible effect on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or other healthcare professional.

How to use Cernitol Novum

Always use Cernitol Novum exactly according to the instructions in this leaflet or according to the instructions of your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.

Adults and older men: The recommended dose is 1 film-coated tablet 3 times daily. The tablet should be swallowed whole with liquid.

The effect of Cernitol Novum is achieved gradually and it can take up to three months before the full effect is achieved. The treatment should then be continued to maintain the effect.

There is no use of Cernitol Novum in women, children, or adolescents.

If you forget to take Cernitol Novum

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Cernitol Novum can cause side effects, although not everybody gets them.

Rare cases of nausea, diarrhea, and hypersensitivity reactions such as rash have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Cernitol Novum

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. date. 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.

6. Contents of the packaging and other information

Content declaration

The active substances in 1 film-coated tablet are:

40 mg dry extract of dried raw pollen from Secale cereale L. (rye), Phleum pratense L. (Timothy) and Zea mays L. (maize) in the ratios 30: 1.5: 1.

Extractant: water: acetone: sodium lauryl sulphate (96: 4: 0.022 m / m / m).

6.6 mg thick extract of dried raw pollen from Secale cereale L. (rye), Phleum pretense. (timothy) and Zea mays L. (maize) in the ratios 30: 1.5: 1.

First extractant: water: acetone: sodium lauryl sulphate (96: 4: 0.022 m / m / m). 
The second extractant: acetone.

The other ingredients are microcrystalline cellulose, maltodextrin, croscarmellose sodium, silica, polyvinyl alcohol, titanium dioxide (E171), macrogol, and talc.

What the medicine looks like and the contents of the pack

Cernitol Novum tablets are white, oval, film-coated tablets.

Cernitol Novum tablets are packaged in plastic jars of 150 or 300 tablets each.

Marketing Authorization Holder and Manufacturer

AB Cernelle

Höganäsvägen 365

SE-262 94 Ängelholm

Email: info@cernelle.se

This medicinal product is authorized under the European Economic Area under the names:

France: CERNITOL 47 mg, compressed pill

Austria: CERNITOL NOVUM film tablet

Muhammad Nadeem

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